During an in clinic follow-up, it was noted the was a failure to capture on the device.Additionally, it was noted the device was unable to be interrogated using inductive telemetry and there was no magnet response from the device.Premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable.
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The reported events of premature discharge of battery, failure to capture, and failure to interrogate 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 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.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, depleting the battery prematurely.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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