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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