It was reported that the device was in backup mode during an in clinic follow-up.The device is explanted and replaced to resolve the event and the patient was in stable condition.The device is included in the zenex, assurity, endurity laser adhesion preparation advisory issued by abbott on 20 july 2022 for a subset of devices distributed and implanted outside of the united states.
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The reported event of backup mode was confirmed.The device was received with no telemetry communication and backup mode outputs were noted.A visual inspection of the header attachment area detected an anomaly between the pre-molded header and titanium case.The device was cut open to enable further testing and the battery was found at normal level.A feed through leak test was performed, indicating a device hermeticity breach.This is consistent with feed through damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the zenex, assurity, endurity laser adhesion preparation advisory issued by abbott on 20 july 2022 for a subset of devices distributed and implanted outside of the united states.
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