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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01184-1
Product Name/Description NM Implantable Pulse Generator within the Infinity and Proclaim device families

Recall for product correction
ARTG Numbers: 277755, 277756

Hazard Alert
Implantable Pulse Generator
ARTG Numbers: 279015, 279016, 282999, 283000, 289235, 278846, 278847, 278849 and 278850
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 15/09/2017
Responsible Entity St Jude Medical Australia Pty Ltd
Reason/Issue Abbott has become aware of instances in which the elective replacement indicator (ERI) in some devices has triggered earlier than intended. In these cases, the ERI alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (IPG).

ERI alerts estimate battery life based on programmed device parameters and patient usage and are unique to each patient. Importantly, please note that this issue is an error in software calculation and is not an indication of the devices’ actual battery performance.

Currently, all implanted IPGs within the Infinity and Proclaim families are affected by this issue.
Recall Action Recall for Product Correction
Recall Action Instructions 1. If an ERI message is displayed on the PC, contact Abbott to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps supplied in the letter.
2. Follow-up communication from Abbott will be provided in order to make appropriate decisions. Either by:
- ERI is valid at this time for this device, follow existing information provided by IFU and CP for the elective replacement window for this device.
- The device has the appropriate level of battery voltage to provide the existing therapy until the next assessment, which should occur no later than March 2018. During this period, the ERI message will be displayed on the PC at the start of each session and may be dismissed.
3. Abbott will deploy a software upgrade that addresses the errors in calculation causing the inappropriate ERI message. Notification of the availability of this software update will occur through the Apple Public App Store for the PC and through the SJM App Catalogue for the CP.

This action has been closed out on the 03/12/2018.
Contact Information 1800 839 259 - Abbott Customer Service