It was reported that the device was not providing pacing support during an in clinic follow-up.As a result, the patient experienced syncope.The device was 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.
|
The reported event of loss of pacing was confirmed.The device was received with no telemetry communication and no output.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 depleted.A 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.The 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 and resulting in the reported events.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.This 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.
|