Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning Model 5392 Dual-Chamber External Pulse Generator (EPG) [Serial number equal or lower than DJH009999P].
The manufacturer has received reports that the negative terminal of a commercially available AA (LR6) battery did not maintain sufficient connection with the battery drawer electrical contact. This could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
The manufacturer advises users to use AA (LR6) batteries where the negative terminal does not have an indentation and has also introduced a new battery drawer contact that is compatible with all AA (LR6) batteries.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 March 2015