It was reported that the patient was admitted to the emergency room with fatigue, syncope, and low heart rate.Upon interrogation, it was revealed that the pacemaker triggered elective replacement indicator (eri) on (b)(6) 2020 and was at end of service (eos) on (b)(6) 2020.The patient has third degree heart block and was symptomatic.Review of merlin transmissions revealed that the device longevity estimate was high during the previous month; premature battery depletion was suspected.The device was explanted and replaced on (b)(6) 2020.The patient was stable after the procedure.
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The reported events of no pacing output and premature battery depletion were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.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.As a result of this finding, abbott is performing further investigation.
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