BRADYCARDIA

MANAGEMENT

HIS-BUNDLE PACING:
C315HIS DELIVERY CATHETER
IMPLANT PROCEDURE
HIS-BUNDLE PACING: C315HIS DELIVERY CATHETER IMPLANT
PROCEDURE

MEDTRONIC This training is provided for general educational purposes only

DISCLOSURE and should not be considered the exclusive source of this type of
STATEMENT information. The content will be shared with physicians and
allied health professionals who seek a deeper understanding of
the operation and use of Medtronic products and therapies with
the intent of enhancing their knowledge of features and
operations described in the clinician manuals. Patent information
(names, serial numbers, date, etc.) has been changed or removed
to protect the privacy of the patients used in this course.

At all times, it is the professional responsibility of the practitioner

to exercise independent clinical judgement in a particular
situation. Changes in a patient’s disease and/or medications may
alter the efficacy of a device’s functionality and programming
described in this course are based on Medtronic products and can
be referenced in the published device manuals.
LEARNING OBJECTIVES

In this course, you will be able to:

• Describe the His-bundle implant procedure using the C315HIS Delivery Catheter and the SelectSecure™ MRI
SureScan™ Model 3830 Lead

Optional:
• Recognize His-bundle capture on an ECG and the various morphologies that may occur
• Identify QRS width and H-V interval and explain how they are measured

For a refresher on His-bundle pacing definitions and the tools available for the procedure,
refer to the His-Bundle Pacing: Clinical Evidence, Leads, and Catheters course.
HIS-BUNDLE PACING: C315HIS DELIVERY CATHETER IMPLANT
PROCEDURE

C315 HIS
DELIVERY
CATHETER

Disclaimer:

This information is provided for general educational purposes only and should
not be considered the exclusive source for this type of information. At all times,
it is the professional responsibility of the practitioner to exercise independent
clinical judgment in a particular situation. Changes in a patient’s disease and/or
medications may alter the efficacy of a device’s programmed parameters or
related features and results may vary.

The content in the videos was provided by physician faculty.

 
 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Prepare the catheter

 Obtain access using the preferred method1,2
─ 7 Fr sheath optional (but recommended)
─ 9 Fr sheath required (if retaining guidewire)
 Remove the .035 guidewire and insert the 3830 lead1-3
 Place the Black clip onto the tip electrode 3-6
 Place the Red clip onto the patient’s skin or to an instrument connected to the skin 3-6
C315HIS ─ 2090 programmer with 2290 analyzer: use the Model 5833SL cable and atrial analyzer channel
─ CareLink SmartSync Device Manager: use the Model 5833SL cable and ventricular analyzer channel
Delivery Catheter
 Set the sweep speed to at least 50 mm/sec
 Set the pulse width to 1.0 millisecond3-6
─ 2090 programmer with the 2290 analyzer: set the Atrial pulse width to 1.0 millisecond
─ CareLink SmartSync Device Manager: set the Ventricular pulse width to 1.0 millisecond
 Increase the gain to maximize the His EGM and consider changing the sensitivity on the analyzer to most sensitive
 Select this link to learn more about the SmartSync EGM gain feature.

1 Medtronic C315H20, C315H40, C315HIS, C315J, C315S4, C315S5, C315S10 Delivery Catheter. Instructions for Use, 2016.
2 Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
3 Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362 – 1366.

4 Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.

5 Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.

6 Medtronic Global Grand Rounds. His-bundle pacing: Tell Me More – Drs. Ellenbogen, Lustgarten, Vijayaraman, & Dandamudi. February 2016.
IMPLANT PROCEDURE

EP RECORDING SYSTEM CONNECTIONS

 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Carefully advance the 3830 lead outside of the C315HIS catheter 1, 3-5
• Only the tip needs to be barely exposed to record a His potential 3-5
• Backup pacing should be readily available during implant
• Rate of transient heart block may be higher for patients with high-grade AV block or LBBB
• Transient HV block, RBBB, or permanent RBBB can occur from lead implantation in the His bundle
 Manipulate the C315HIS catheter until a clear His potential is observed 3-5
 Note: C315HIS hub is in the same plane as the distal curve
C315HIS C304-HIS white hub grip is in a similar plane to the proximal curve
Delivery Catheter  Advance the C315HIS catheter as far as possible over the 3830 lead 1,2,4
 Recheck the signal to ensure a His potential is still visible 2,4

1
Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
2
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362 – 1366.
3
Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.
4
Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.
5
Medtronic Global Grand Rounds. His-bundle pacing: Tell Me More – Drs. Ellenbogen, Lustgarten, Vijayaraman, & Dandamudi. February 2016.
 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Rotate the entire lead body clockwise 4-5 complete turns1

• Lead should rotate back 1-2 turns which likely confirms adequate anchoring in the His region
 Gently advance the lead to provide lead slack and prevent tip dislodgment 1 while withdrawing the C304-HIS
deflectable catheter 2-4 inches (5 to 10 cm) to test lead stability 2

Note:
C315HIS In the case of dislodgment or reposition, consider removing the 3830 lead and check to ensure there is no tissue stuck
Delivery Catheter in the helix1

Consider stabilizing the catheter position, if torque has been applied, to avoid movement during fixation.

1
Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
2
Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.
3
Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.
 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Test R-wave amplitude1,2

 Pull the guide catheter back to expose the ring electrode of the lead 1
 R-waves as low as 1-2 mV are acceptable provided you can avoid far-field
atrial oversensing2
HOW ARE THE QRS WIDTH
 Measure the QRS width and HV interval during high output pacing
• Typically start at 5V @ 1 ms2 AND
• Useful to note and compare to intrinsic H-V INTERVAL MEASURED?
C315HIS  Run a threshold test, decrementing voltage over time2 Select each to learn more.
Delivery Catheter • Note: You may obtain more than one threshold: His threshold, RV capture QRS WIDTH AND H-V INTERVAL
threshold, and bundle branch recruitment threshold
TYPES OF CAPTURE

NARROW/WIDE INTRINSIC QRS

1
Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
2
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362-1366.
 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Slit the C315HIS catheter

 Observe lead stability under fluoroscopy1,2
• It is extremely important to allow adequate lead slack before slitting the catheter2
• The lead may not easily advance forward once the sheath is removed since it is not steerable with a stylet 2
• Avoid excessive slack buildup that may cause the loop of the lead to drop near the tricuspid valve 2
 Retest R-wave amplitude and His/RV capture thresholds2-6
• Test in both unipolar and bipolar configurations3-6
• Consider patient’s pacing dependency
C315HIS • If HB injury current is noted, the His threshold may improve even if it’s higher at fixation 3-6
Delivery Catheter

1
Medtronic C315H20, C315H40, C315HIS, C315J, C315S4, C315S5, C315S10 Delivery Catheter. Instructions for Use, 2016.
2
Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
3
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362-1366.
4
Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.
5
Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.
6
Medtronic Global Grand Rounds. His-bundle pacing: Tell Me More – Drs. Ellenbogen, Lustgarten, Vijayaraman, & Dandamudi. February 2016.
 IMPLANT PROCEDURE

Place the Atrial

Map the Test the His
Obtain Access Fixate the Lead Slit the Catheter Lead & Select
His Bundle Bundle Location
Device

 Program the device with appropriate safety margins for His/RV capture and Sensitivity 1-6
 Sensitivity ranges vary depending on pacemaker model
 Settings can range from 0.45mV to 11.3mV or 1.0mV to 11.2mV
 Set outputs of the device to capture the His bundle while considering device longevity 1-3
• Consult the manual for longevity tables at http://manuals.medtronic.com/manuals/main/region
• For high output situations, consider using a large-capacity battery device 3
• For low R-wave situations, consider using a device that provides higher sensitivity and the ability for the patient to have an MRI 3
C315HIS
Delivery Catheter  Visit mrisurescan.com to determine if an implanted system is MR Conditional

1
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362-1366.
2
Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.
3
Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.
4
Medtronic Global Grand Rounds. His-bundle pacing: Tell Me More – Drs. Ellenbogen, Lustgarten, Vijayaraman, & Dandamudi. February 2016.
5
Medtronic Azure™ XT DR MRI SureScan™ W1DR01. Device Manual. 2016.
6
Medtronic Attesta ATDR01. Device Manual. 2017.
IMPLANT PROCEDURE

TIPS & TECHNIQUES

 Use 12 lead ECG monitoring during implant1-3
 His bundle mapping using the PSA3
 Use Maximal gain settings of 0.05mV @ 50 mm/sec sweep speed 3
 Printing on the paper may show the His signal better than the PSA monitor
 Use the electronic calipers in the Analyzer to measure AH and HV intervals, as needed
 Consider mapping the His using the lead in the unipolar configuration 2,3
 While mapping with the C315HIS sheath:
 Gentle clockwise rotation will point the lead towards the superior AV septum and more towards the RV region 2,3
 Counterclockwise rotation will direct the lead towards the mid to posterior septum and the atrial region 2,3
 When His bundle signal cannot be identified, high output pacing (5-10V @ 1 ms) at the AV annular or slightly
ventricular location can identify the His region (Pace-mapping)
 Especially in patients with complete heart block
 Varying pacing outputs can show His+RV fusion complexes and pure RV paced complexes 3
 Important to feel the torque during/after fixing the lead to achieve stable fixation 2,3

1 Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.

2 Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362-1366.
3 Vijayaraman P , Dandamudi G. How to Perform Permanent His Bundle Pacing: Tips and Tricks. PACE. 2016; (39): 1298-1300.

4 Medtronic Global Grand Rounds. His-bundle pacing: Training with the Experts – Drs. Dandamudi and Vijayaraman. October 2016.

5 Medtronic Global Grand Rounds. His-bundle pacing: Tell Me More – Drs. Ellenbogen, Lustgarten, Vijayaraman, & Dandamudi. February 2016.
IMPLANT PROCEDURE

PROGRAMMING
 ~10% of patients may develop sub-acute increase in His bundle capture
threshold1
 To provide an adequate safety margin (1.5 - 2.0 x), select a pacing voltage
twice the chronic stimulation threshold voltage for a given pulse width 2
 Programmed AV delay should be programmed shorter than the standard
parameters
 Typical programmed AV delay should be at least 40-50ms shorter than the
standard parameters to account for His-Purkinje conduction 3 Shortened AV delays promoting nSHBP
 Atrial capture or far-field atrial oversensing may be experienced
 His potential oversensing may occasionally be experienced
 Plan sensitivity and pacing output programming accordingly4
 Physician’s discretion to:
 Evaluate capture management performance
 Determine whether capture management should be On or Off based on patient
conditions

Oversensing the His potential

1
Dandamudi G, Vijayaraman P, How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362 – 1366.
2
Medtronic Adapta, Versa, Sensia, Relia Pacemaker Reference Guide. http://manuals.medtronic.com/manuals/
3
Sohaib S, Wright I, Lim E, et al. Atrioventricular Optimized Direct His Bundle Pacing Improves Acute Hemodynamic Function in Patients With Heart Failure and PR Interval Prolongation Without Left Bundle Branch Block.
JACCCEP. 2015; 1(6): 582-591.
4
Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.
IMPLANT PROCEDURE

PROGRAMMING

His-bundle Capture Atrial Capture

Check for atrial capture during HBP1
 When Stim-V interval is short (40-60 ms) there
is HBP capture

 When Stim-V interval is long (> 100 ms) there

is atrial capture

Image: Courtesy of Ellenbogen, K. Electrophysiology Division, Medical College of Virginia/VCU School of Medicine, Richmond, Virginia.
1
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016; 13(6): 1362 – 1366.
KNOWLEDGE CHECK

QUESTION #1
When testing the His-bundle location, which of the following were recommended by Dr. Vijayaraman and
Dr. Dandamudi?
Select all that apply.

 a. R-waves as low as 1-2mV are acceptable provided you can avoid far-field atrial oversensing.

 b. Run a threshold test starting at a high output, decrementing voltage over time. You may obtain
more than one threshold: His threshold, RV capture threshold, and bundle branch recruitment threshold.

 c. Via 12-lead or other surface ECG, measure the QRS width and HV interval during high output
pacing. It is important to program the output at least 1-2 V above His capture threshold.

Select to view the answer

 KNOWLEDGE CHECK

QUESTION #1: CORRECT ANSWER

When testing the His-bundle location, which of the following were recommended by Dr. Vijayaraman and
Dr. Dandamudi?
Select all that apply.

 a. R-waves as low as 1-2mV are acceptable provided you can avoid far-field atrial oversensing.

 b. Run a threshold test starting at a high output, decrementing voltage over time. You may obtain
more than one threshold: His threshold, RV capture threshold, and bundle branch recruitment threshold.

 c. Via 12-lead or other surface ECG, measure the QRS width and HV interval during high output
pacing. It is important to program the output at least 1-2 V above His capture threshold.

Medtronic SelectSecure™ MRI SureScan™ 3830. Technical Manual. 2018.

HIS-BUNDLE PACING: C315HIS DELIVERY CATHETER IMPLANT PROCEDURE

Six key implant procedure steps

 Obtain access
WRAP UP  Map the His bundle
 Fixate the lead
 Test the His bundle location
 Slit the catheter
 Place the atrial lead and select the appropriate device
 HIS-BUNDLE PACING: C315HIS DELIVERY CATHETER IMPLANT PROCEDURE

CONGRATULATIONS In this course, you learned about techniques for implanting

the SelectSecure MRI SureScan Model 3830 lead at the
You have completed the course His-bundle Pacing: bundle of His using the C315HIS delivery catheter.
C315HIS Delivery Catheter Implant Procedure.
Select the Resources button to access downloadable
materials and to review the safety information for this course.

Select the Menu button to return to any of the course content.

Select “Exit Course” to leave the course.

EXIT COURSE
RESOURCES

To access additional information regarding His-bundle pacing, visit:

www.MedtronicAcademy.com/HisBundlePacing

To access the listed information directly, select the links below:

Global Grand Rounds
─ His-bundle Pacing: Tell Me More
─ His-bundle Pacing: Training with the Experts
 INDICATIONS, SAFETY, AND WARNINGS

If you are located in the United States, please refer to the brief statements below to review applicable indications, safety and warning information. See the
device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1.763.514.4000 and/or consult the Medtronic website at
www.medtronic.com.
If you are located outside the United States, see the device manual for detailed information regarding instructions for use, the implant procedure,
indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan device, see the MRI SureScan™ technical
manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at
www.medtronic.com.

Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader ®
with the browser.

Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as
indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have
authorization for use.

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BRIEF STATEMENT

Product Safety Information

Brief Statement: IPGs, CRT IPGs, ICDs, and CRT ICDs

Indications
Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Pacemakers are also indicated for dual chamber
and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV
synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm. See device manuals for
the accepted patient conditions warranting chronic cardiac pacing.  Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in patients with one or more of the above pacing indications.  For the
MR Conditional IPGs, a complete SureScan® pacing system, which consists of an approved combination (see http://www.mrisurescan.com) MRI SureScan device with SureScan lead(s), is required for use in the MR
environment.
Cardiac Resynchronization Therapy (CRT) IPGs are indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35% and a
prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50%, are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are
expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing.  Optimization of heart failure medical therapy that is limited due to AV block or the
urgent need for pacing should be done post implant.  Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in
activity.  Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.  Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in
patients with one or more of the above pacing indications.
Implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  Notes on some
features in ICDs: The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. Additional notes for DR
ICDs: The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device
classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. The effectiveness of high-frequency burst
pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to be 18.2% in the AF-only patient
population studied. 
CRT ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for providing cardiac resynchronization therapy in heart
failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications: New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular
ejection fraction < 35% and a prolonged QRS duration. Left bundle branch block (LBBB) with a QRS duration > 130 ms, left ventricular ejection fraction < 30%, and NYHA Functional Class II. NYHA Functional Class I,
II, or III and who have left ventricular ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize
right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Some ICDs and CRT ICDs are also indicated for use in
patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.  The RV Lead Integrity Alert (LIA) feature is intended primarily for patients who have a Medtronic
ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data. The RV LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific
Endotak lead as it does when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA
feature. 

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BRIEF STATEMENT

Product Safety Information

Brief Statement: IPGs, CRT IPGs, ICDs, and CRT ICDs (cont.)

Contraindications
IPGs and CRT IPGs are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator.  There are no known contraindications for the use
of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician.   Rate-
responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.  Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or flutter.  Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.  Single chamber atrial pacing
is contraindicated in patients with an AV conduction disturbance.  Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway. 
ICDs and CRT ICDs are contraindicated in patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning,
electric shock, electrolyte imbalance, hypoxia, or sepsis; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary
disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. 
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device.
Additionally, for CRT ICDs and CRT IPGs, certain programming and device operations may not provide cardiac resynchronization.  Also for CRT IPGs, Elective Replacement Indicator (ERI) results in the device switching
to VVI pacing at 65 ppm.  In this mode, patients may experience loss of cardiac resynchronization therapy and / or loss of AV synchrony.  For this reason, the device should be replaced prior to ERI being set. Use of the
device should not change the application of established anticoagulation protocols.
For MR Conditional IPG Systems, before performing an MRI scan, refer to the Surescan pacing system technical manual for additional information, patients and their implanted systems must be screened to meet the MRI
Conditions of Use. Do not scan patients who do not have a complete SureScan pacing system consisting of an approved combination MRI SureScan device with SureScan lead(s); patients who have broken, abandoned or
intermittent leads; or patients who have a lead impedance value of < 200 Ω or > 1,500 Ω.
Potential complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical
complications such as hematoma, infection, inflammation, and thrombosis. 
An additional complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia.
SureScan systems have been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of
sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call
Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com. 
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Updated Nov 10 2015

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BRIEF STATEMENT

Product Safety Information

Brief Statement: Azure™ MRI SureScan™ SR and DR IPG

Indications
The Azure DR MRI and Azure SR MRI SureScan systems are indicated for the rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Accepted patient conditions
warranting chronic cardiac pacing include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions
with or without associated AV conduction disorders, or bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.
The Azure DR MRI devices are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of
conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker
syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia
patients with one or more of the above pacing indications.
MRI Conditions for Use:
Medtronic SureScan pacing systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Pacemaker SureScan system patients may be scanned using a
horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to
provide appropriate pacing. 
A complete SureScan pacing system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit  
http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.
Contraindications
The Azure DR MRI and Azure SR MRI SureScan systems are contraindicated for concomitant implantation with another bradycardia device or with an implantable cardioverter defibrillator. Rate-responsive modes may be
contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias,
including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients
with an AV conduction disturbance. ATP therapy is contraindicated in patients with an accessory antegrade pathway.

Warnings and Precautions

Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device
should not change the application of established anticoagulation protocols.
Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as
confirmed by lead impedance history; the device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region. 

3
BRIEF STATEMENT

Product Safety Information

Brief Statement: Azure™ MRI SureScan™ SR and DR IPG (cont.)
 
Potential Adverse Events or Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of
tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air
embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement,
lead conductor fracture, insulation failure, threshold elevation, or exit block. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or
both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.
See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications.
For further information, call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com .
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

3
BRIEF STATEMENT

Product Safety Information

Brief Statement: Transvenous SureScan™ Pacing Systems

The SureScan transvenous Advisa MRI™ and Revo MRI™ pacing systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. When programmed to On,
the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.  A complete SureScan system, which is a SureScan device with appropriate SureScan lead(s), is
required for use in the MR environment.  To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/.   Any other combination may result in a hazard to the patient during an MRI scan.
Indications 
SureScan pacing systems are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity.  Accepted patient conditions warranting chronic cardiac pacing
include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV
conduction disorders, or bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.  Dual chamber SureScan pacing systems are also indicated for dual chamber
and atrial tracking modes in patients who may benefit from maintenance of AV synchrony.  Dual chamber modes are specifically indicated  for treatment of conduction disorders that require restoration of both rate and AV
synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm, or vasovagal
syndromes or hypersensitive carotid sinus syndromes.  Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.
Contraindications 
SureScan pacing systems are contraindicated for implantation with unipolar pacing leads (Revo MRI only), concomitant implantation with another bradycardia device or an implantable cardioverter defibrillator.  Rate-
responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.  Dual chamber sequential pacing is contraindicated in patients with chronic or persistent
supraventricular tachycardias, including atrial fibrillation or flutter.  Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.  Single chamber atrial pacing
is contraindicated in patients with an AV conduction disturbance.  ATP therapy is contraindicated in patients with an accessory antegrade pathway. 

Warnings and Precautions 

Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage.  Do not place transthoracic defibrillation paddles directly over the device.
Patients and their implanted systems must be screened to meet the following requirements for MRI: 
No lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service
life, and the system must be implanted in the left or right pectoral region.  For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is
greater than 2.0 V at 0.4 ms.  Patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on must have no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width
of 1.0 ms.  It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks). 

3
BRIEF STATEMENT

Product Safety Information

Brief Statement: Transvenous SureScan™ Pacing Systems (cont.)

Warnings and Precautions (cont.) 

Pace polarity parameters are set to Bipolar for programming MRI SureScan to On (Advisa MRI only); or a SureScan pacing system is implanted with a lead impedance value of ≥ 200 Ω and ≤ 1500 Ω.  Revo MRI patients
must have pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms and a SureScan pacing system that has been implanted for a minimum of 6 weeks.
Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤
200 T/m/s.  1.5T scanners must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg).  3T scanners must be operated in First Level Controlled
Operating Mode or Normal Operating Mode.   B1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra.  Scans can be performed without B1+RMS restriction when the isocenter is at
or superior to the C7 vertebra. Revo MRI can only be scanned using 1.5T systems.
For SureScan pacing systems, proper patient monitoring must be provided during the MRI scan.  

Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of
tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.  Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air
embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax.  Other potential complications related to the lead may include lead dislodgement,
lead conductor fracture, insulation failure, threshold elevation, or exit block.  Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or
both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.  
See the appropriate product MRI SureScan Technical Manual before performing an MRI Scan and see the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events.  For further information, call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

3
BRIEF STATEMENT

Product Safety Information

Brief Statement: General Right Heart MRI SureScan Pacing and Sensing Lead
Indications
Medtronic leads have application where implantable atrial and/or ventricular, single or dual chamber pacing systems are indicated. Leads are intended for pacing and sensing in the right atrium and/or ventricle.
MRI SureScan™ leads (which include specified lengths of Models 5076, 4076, 4074, 4574, 5086MRI and 3830; consult individual lead model technical manuals for more detail) are indicated for use as a system consisting
of an indicated Medtronic MRI SureScan device, implanted with SureScan leads. A complete system is required for use in the MRI environment.
Medtronic SelectSecure MRI 3830 family of leads is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternate to right ventricular pacing in
a single or dual chamber pacing system, which include specified lengths; consult individual lead model technical manuals for more detail.
Contraindications
Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease and/or patients with mechanical tricuspid heart valves.
Do not use in patients for whom a single dose of dexamethasone acetate and/or dexamethasone sodium acetate or beclomethasone dipropionate may be contraindicated (applies to all leads that contain these steroid
configurations; see model manuals for specific steroid and dosage).
The SelectSecure™ Model 3830 Lead is also contraindicated for the following: Patients with obstructed or inadequate vasculature for intravenous catheterization.
Warnings and Precautions
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious
injury or damage to an implanted device and lead system. Some lead models allow the use of therapeutic ultrasound; consult individual lead model technical manuals for more detail.
For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-
dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied.
Do not use magnetic resonance imaging (MRI) on patients who have non-MR conditional versions/lengths of these leads implanted as part of a complete SureScan System. MRI can induce currents on implanted leads,
potentially causing tissue damage and the induction of tachyarrhythmias.

MRI SureScan Leads only: A complete SureScan pacing or defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI Technical Manual for MRI-specific warnings
and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with
intermittent electrical contact as confirmed by lead impedance history; a SureScan defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; no
diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On.
Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging.

3
BRIEF STATEMENT

Product Safety Information

Brief Statement: General Right Heart MRI SureScan Pacing and Sensing Lead (cont.)

Potential Complications
Potential patient-related complications related to the use of transvenous leads include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall
rupturez, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential lead-related complications may include exit block,
lead dislodgement, lead fracture, insulation failure, and threshold elevation.
Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF,
and/or hemodynamic collapse.
See the appropriate Device MRI SureScan Technical Manual before performing an MRI Scan and Lead Technical Manual for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rev 08/18

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: SelectSecure and SelectSecure MRI SureScan Pacing and Sensing Lead
Indications
Medtronic SelectSecure family of leads has application where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The Model 3830 lead is intended for pacing and sensing in the
atrium or ventricle.
Medtronic SelectSecure MRI family of leads is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a
single or dual chamber pacing system.
SelectSecure MRI SureScan™ leads (specified lengths of Model 3830 including 59, 69 and 74 cm) are MR conditional and indicated for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in
a single or dual chamber pacing system. The Model 3830 lead is part of the Medtronic SureScan system. The SureScan system includes a Medtronic SureScan device connected to Medtronic SureScan leads.

Contraindications
SelectSecure lead family is contraindicated for the following:
• ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
• patients for whom a single dose of beclomethasone dipropionate may be contraindicated; see manual for specific dosage.
The SelectSecure™ Model 3830 Lead is also contraindicated for the following: Patients with obstructed or inadequate vasculature for intravenous catheterization.

Warnings and Precautions

People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious
injury or damage to an implanted device and lead system. Some lead models allow the use of therapeutic ultrasound; consult individual lead model technical manuals for more detail.
For Model 3830, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been
described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied.
Do not use magnetic resonance imaging (MRI) on patients who have non-MR conditional versions/lengths of these leads implanted as part of a complete SureScan System. MRI can induce currents on implanted leads,
potentially causing tissue damage and the induction of tachyarrhythmias.
MRI SureScan Leads only: A complete SureScan pacing or defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI Technical Manual for MRI-specific warnings
and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent
electrical contact as confirmed by lead impedance history; a SureScan defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; no diaphragmatic
stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On. Patients may be scanned
using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging.

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: SelectSecure and SelectSecure MRI SureScan Pacing and Sensing Lead (cont.)

Potential Complications
Potential patient-related complications related to the use of transvenous leads include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall
rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential lead-related complications may include exit block, lead
dislodgement, lead fracture, insulation failure, and threshold elevation.
Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF,
and/or hemodynamic collapse.
See the appropriate Device MRI SureScan Technical Manual before performing an MRI Scan and Lead Technical Manual for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rev 08/18

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: C315 Catheter

Indications (or Intended Use)

The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Contraindications
Use of the C315 percutaneous catheter is contraindicated in patients with obstructed or inadequate vasculature.
Warnings/Precautions
• This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the
device or create a risk of contamination of the device that could result in patient injury, illness, or death.
• Keep external defibrillation equipment nearby for immediate use during insertion, placement, acute lead system testing, or whenever arrhythmias are possible or intentionally induced. Backup pacing should be readily
available during implant. Use of a delivery system and/or leads may cause heart block. For further information about this and other potential adverse events or complications, refer to the technical manual packaged with
the appropriate product.
• Use care when passing a catheter through vessels and tissue. Avoid damage, such as perforations and dissections, to vessels and cardiac tissue, during catheter passage and positioning. Do not push, pull, or rotate the
catheter against resistance. If resistance is met, discontinue movement, determine the reason for resistance, and take appropriate action before continuing. Damage to the catheter may prevent it from performing with
accurate torque response and control, and may cause vessel damage.
• Use the catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of any non-Medtronic device with the catheter. Consequences of using the catheter with incompatible
devices may include the inability to deliver the transvenous device or damage to the transvenous device or catheter during delivery. Slitting evaluations on this product were conducted using Medtronic Universal II or
Medtronic Adjustable Slitters. These are the only slitters recommended for use with the C315 catheter.
• Handle the catheter with care at all times. Do not kink, stretch, or severely bend the catheter. Do not use surgical instruments to grasp the catheter. Do not use excessive force when inserting a catheter into a vessel.
Ensure the catheter is thoroughly flushed and free of air prior to use. Avoid contact with liquids other than blood, saline, or contrast solution. Use in conjunction with fluoroscopic guidance and proper anticoagulation
agents.
• Use the side port on the hub to flush the catheter. The catheter must be thoroughly flushed and free of air prior to use. When using the side port, consider sealing the proximal opening of the hemostatic valve with a thumb
or forefinger.
Potential Complications
Air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma
formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.
See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information,
please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rev 1A

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: SelectSiteTM C304-HIS Deflectable Catheter System

Indications
The device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into
the coronary sinus or leads into vessels of the left
heart via the coronary sinus.
Contraindications
Use of the device is contraindicated for patients with obstructed or inadequate vasculature and for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.
Warnings/Precautions
• The device is for single use only and is not intended to be resterilized.
• Use the deflectable catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of the deflectable catheter with any device not manufactured by Medtronic. For the C304-HIS
Catheters, no test data is available to demonstrate compatibility of the transvenous devices with an outer diameter larger than 1.5mm (4.6Fr), with the exception of the 1.85mm (5.6Fr) dilator included with the device
package. Consequences of using the deflectable catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.
• Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product.
• Handle the deflectable catheter with care at all times. Do not kink, stretch, or severely bend the deflectable catheter. Do not use surgical instruments to grasp the deflectable catheter. Avoid contact with liquids other than
isopropyl alcohol, blood, saline, or contrast solution.
• Use the valve to impede the back flow of venous blood during the implant procedure. Ensure that the flush port stopcock is closed before attaching the valve to the deflectable catheter hub.
• Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during post-implant testing.
Potential Complications
The following are known potential complications related to the use of the deflectable catheter system: air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial
plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery
puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, and vessel damage.
 
See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information,
please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rev 1A

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: C304 SelectSiteTM Catheter

Indications (or Intended Use)

The device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into
the coronary sinus or leads into vessels of the left heart via the coronary sinus.
Contraindications
Use of the device is contraindicated for patients with obstructed or inadequate vasculature and for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.
Warnings/Precautions
• The device is for single use only and is not intended to be resterilized.
• Use the deflectable catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of the deflectable catheter with any device not manufactured by Medtronic. For the C304
Catheters, no test data is available to demonstrate compatibility of the transvenous devices with an outer diameter larger that 1.5mm (4.6Fr), with the exception of the 1.85mm (5.6Fr) dilator included with the device
package. Consequences of using the deflectable catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.
• Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product.
• Handle the deflectable catheter with care at all times. Do not kink, stretch, or severely bend the deflectable catheter. Do not use surgical instruments to grasp the deflectable catheter. Avoid contact with liquids other than
isopropyl alcohol, blood, saline, or contrast solution.
• Use the valve to impede the back flow of venous blood during the implant procedure. Ensure that the flush port stopcock is closed before attaching the valve to the deflectable catheter hub.
• Keep external defibrillation and backup pacing readily available during implant. Use of the device, transvenous devices, or both may cause heart block.

Potential Complications
Potential adverse events related to the use of the deflectable catheter may include, but are not limited to, the following events: air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the
insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation,
pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.
 
See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information,
please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Rev 1A

4
BRIEF STATEMENT

Product Safety Information

Brief Statement: Medtronic Model 24970A CareLink Smart Sync™ Device Manager Base and Model 24967 Patient Connector and associated apps

Medtronic Model 24970A CareLink SmartSync Device Manager Base and associated apps:
Indications
The base is intended to be used as part of the CareLink SmartSync Device Manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant
or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by
healthcare professionals only in operating environments under direct medical supervision.
Contraindications
The base is not intended for use as an external pulse generator (EPG) outside of the implant procedure. In addition, the patient’s age and medical condition may dictate the lead analyses
appropriate for the patient.
See the CareLink SmartSync™ 24970A and Technical Manual and 24967 Patient Connector Technical Manual before using the CareLink SmartSync Device Manager for detailed information
regarding the procedure, indications or intended uses, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at
1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Medtronic Model 24967 Patient Connector and associated apps:

Indications
The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices. The patient connector uses Bluetooth technology to
transmit that data to a Medtronic app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.
Precautions
Security – Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is
encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.
See the 24967 Patient Connector Technical Manual before using the CareLink SmartSync Device Manager for detailed information regarding the procedure, indications or intended uses,
contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

4
Medtronic
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