The device was returned without specific complaint or event.As received, the device had normal telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.Device image showed elevated leakage current.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested by connecting to an external power source.Test 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 (b)(6) 2021.
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