It was reported that the patient presented in clinic for a follow up.Device interrogation revealed noise oversensing, low pacing impedance, failure to capture and premature battery depletion on the pacemaker.The physician elected to explant and replace the pacemaker.The patient was in stable condition.
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The reported events of premature discharge of battery, sensing noise, low pacing impedance and failure to capture were confirmed.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.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.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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