The device was returned without specific complaint or event.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected an 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 the battery was found depleted.Feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Test results indicated elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.
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