User's Manual - SJM

AccentTM, AccentTM RF, Accent MRITM, AccentTM ST, AssurityTM, AssurityTM+, Assurity MRITM, EndurityTM, EndurityTM Core, Endurity MRITM Pulse Generator

AllureTM, AllureTM RF, Allure QuadraTM, Allure QuadraTM RF, AnthemTM, AnthemTM RF, Quadra AllureTM, Quadra Allure MPTM, Quadra Allure MPTM RF Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Unless otherwise noted, TM indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.

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? 2017 St. Jude Medical, LLC. All Rights Reserved.

Device Description

This manual describes the St. Jude MedicalTM pulse generators listed in the table below1. These devices can be programmed with MerlinTM Patient Care System equipped with Model 3330 version 21.2.2 (or greater) software. For information on programming, refer to the programmer's onscreen help.

CAUTION: Not all device models are available in all countries.

Not all of the products listed as MR Conditional are approved for MR Conditional use in all countries or regions.

Before performing an MRI scan on patients implanted with any of these devices, contact St. Jude Medical or consult your regulatory authorities to determine if the products have been certified as MR Conditional.

Table 1. Pulse generator descriptions

Name Accent SR

Model Number

PM1110

Description Single-chamber pulse generator

1 Not all device models are available in all countries. 2 As defined by the American College of Radiology.

1

Connector Type

IS-1

MRI Status2 Untested

Table 1. Pulse generator descriptions

Name

Model Number

Accent MRI Endurity Core Endurity Core Endurity Endurity

PM1124 PM1140 PM1152 PM1160 PM1162

Endurity MRI PM1172 Accent SR RF PM1210

Accent MRI PM1224

Assurity

PM1240

Assurity +

PM1260

Description

Connector Type

Single-chamber pulse generator

IS-1

Single-chamber pulse generator

IS-1

Single-chamber pulse generator

IS-1

Single-chamber pulse generator

IS-1

Single-chamber pulse generator

IS-1

Single-chamber pulse generator

IS-1

Single-chamber pulse generator with IS-1 RF telemetry

Single-chamber pulse generator with IS-1 RF telemetry

Single-chamber pulse generator with IS-1 RF telemetry

Single-chamber pulse generator with IS-1 RF telemetry

MRI Status2

MR Conditional MR Conditional MR Conditional Untested MR Conditional MR Conditional Untested

MR Conditional

Untested

Untested

2

Table 1. Pulse generator descriptions

Name Assurity MRI

Model Number

PM1272

Accent DR Accent ST Accent MRI Endurity Core Endurity Core Endurity Endurity Endurity MRI Accent DR RF

PM2112 PM2122 PM2124 PM2140 PM2152 PM2160 PM2162 PM2172 PM2212

Description

Connector Type

Single-chamber pulse generator with IS-1 RF telemetry

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator

IS-1

Dual-chamber pulse generator with IS-1 RF telemetry

MRI Status2

MR Conditional

Untested Untested MR Conditional MR Conditional MR Conditional Untested MR Conditional MR Conditional Untested

3

Table 1. Pulse generator descriptions

Name Accent MRI

Model Number

PM2224

Assurity

PM2240

Assurity +

PM2260

Assurity MRI PM2272

Anthem Allure Allure Quadra

PM3112 PM3120 PM3140

Description

Dual-chamber pulse generator with RF telemetry Dual-chamber pulse generator with RF telemetry Dual-chamber pulse generator with RF telemetry Dual-chamber pulse generator with RF telemetry CRT-P CRT-P CRT-P

Quadra Allure PM3542 CRT-P

Connector Type IS-1

IS-1

IS-1

IS-1

IS-1 IS-1 IS-1/IS4LLLL IS-1/IS4LLLL

MRI Status2

MR Conditional Untested Untested MR Conditional Untested Untested Untested MR Conditional

4

Table 1. Pulse generator descriptions

Name

Quadra Allure MP Quadra Allure MP Anthem RF Allure RF Allure Quadra RF Quadra Allure MP RF

Model Number PM3160

PM3562

PM3212 PM3222 PM3242

PM3262

Description

CRT-P CRT-P CRT-P with RF telemetry CRT-P with RF telemetry CRT-P with RF telemetry CRT-P with RF telemetry

Connector Type

IS-1/IS4LLLL

IS-1/IS4LLLL

IS-1

IS-1

IS-1/IS4LLLL

IS-1/IS4LLLL

MRI Status2

Untested MR Conditional Untested Untested Untested Untested

5

Indications

Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions3,4,5: Syncope Presyncope Fatigue Disorientation due to arrhythmia/bradycardia Or any combination of those symptoms. Implantation of a CRT-P is indicated for patients who: Would benefit from resynchronization of the right and left ventricles Have one or more conventional indications for the implantation of a pacemaker

3 Brignole M, Auricchio A, Baron-Esquivias G. et al. 2013ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013;34(29):2281-329. 4 Tracy CM, Epstein AE, Darbar D, et al. ACCF/AHA/HR Focused Updated of the 2008Guidelines for Device Based Therapy of Cardiac Rhythm Abnormalities. Circulation 2012;126:1784-1800. 5 Epstein AE, DiMarco JP, Ellenborgen KA, et al. ACC/AHA/HRS 2008Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. J Am Coll Cardiol 2008;51:e1-62.

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