It was reported that during a remote follow up, the device was unable to be interrogated.During a follow up in clinic, the device was unable to be interrogated, there was no magnetic response, and loss of pacing was noted.The device was explanted and replaced to resolve the event.During the replacement procedure, discoloring of the header was observed.The patient was in stable condition.
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The reported events of no lv output, no inductive telemetry, no magnet response, and material discolored were confirmed.The device was received with no telemetry communication and no output.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 in normal ranges.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.Hybrid circuitry was tested, and the results indicated elevated current drain, consistent with moisture damage, resulting in the reported events.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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