It was reported that the device was explanted and replaced prophylactically as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.It was reported there were no patient consequences.
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The reported event was the prophylactic explant of a device that was subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.The device was returned due to advisory with no allegation of a malfunction.Visual inspection of the device and header attachment area did not find any anomalies.Interrogation of the device indicated battery voltage and current within normal range when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).
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