No complaint was received with the return of the device.Failure event observed during analysis.The device was received with normal telemetry and 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.The device met specifications prior to leaving abbott manufacturing facilities.The device was cut open to enable further testing and longevity assessment found the device was operating above the elective replacement indicator (eri) voltage consistent with normal usage.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 (b)(6).2021.
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