No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found, as received, the device output and telemetry communication were normal.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Visual inspection of the header attachment area detected a bonding anomaly.The device was tested for a hermeticity breach which was not observed.The device was cut open to enable further testing and battery was found normal.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.
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