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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00257-1
Product Name/Description Model 5392 Dual-Chamber External Pulse Generator

Serial Numbers equal or lower than DJH009999P

ARTG Number: 128599
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 19/03/2015
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has received reports where the negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is working with hospitals to develop a correction plan. The scheduling of the correction is dependent on the availability of loan devices. In the interim hospitals have been advised to ensure that compatible batteries are used. Medtronic will assist end users in determining compatibility. This action has been closed-out on 1/06/2016.
Contact Information 1800 336 693 - Medtronic Service Team