Accent MRI PM2224 - Pacemaker, cardiac, implantable

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Medical Australia Pty Ltd

Class:

AIMD

Therapeutic area:

Pacemaker, cardiac, implantable

Authorization status:

Included

Patient Information leaflet

Accent™, Accent™ RF, Accent MRI™,
Accent™ ST, Accent™ ST MRI, 
Assurity™, Assurity™ +, Assurity
MRI™, Endurity™, Endurity™ Core, 
Endurity MRI™ 
Pulse Generator 

Allure™, Allure™ RF, Allure Quadra™, Allure Quadra™ RF,
Anthem™, 
Anthem™ RF, Quadra Allure MP™, Quadra Allure MP™ RF 
Cardiac Resynchronization Therapy Pulse Generator 

User's Manual 

Unless otherwise noted, ™ 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, Inc. and its related 
companies. © 2015 St. Jude Medical, Inc. All Rights Reserved. 

DEVICE DESCRIPTION 
This manual describes the St. Jude Medical™ pulse
generators listed in the table below
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. 
These devices can be programmed with Merlin™ Patient Care
System equipped with Model 3330 version 20.0.2 (or greater) 
software. For information on programming, refer to the
programmer's on-screen help. 
CAUTION 
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. 
NOT ALL DEVICE MODELS ARE AVAILABLE IN ALL COUNTRIES. 

Table 1.  Pulse generator descriptions 
NAME 
MODEL NUMBER  DESCRIPTION 
CONNECTOR 
TYPE 
MRI STATUS
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Accent SR 
PM1110 
Single-chamber pulse generator 
IS-1 
Untested 
Accent ST 
PM1122 
Single-chamber pulse generator 
IS-1 
Untested 
Accent MRI 
PM1124 
Single-chamber pulse generator 
IS-1 
MR Conditional 
Accent ST MRI 
PM1126 
Single-chamber pul