It was reported that a patient presented in-clinic.Upon examination, the patient's pacemaker was found to have exhibited loss of output, premature battery depletion, and loss of inductive telemetry.The resulted in a sustained bradycardic episode.The pacemaker was explanted and replaced on (b)(6) 2022.The patient was stable throughout.
|
The reported events of premature discharge of battery, failure to interrogate and no pacing were confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, indicating elevated current drain, consistent with moisture damage, depleting the battery prematurely, and resulting in the reported event.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.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.
|