It was reported that the patient presented remotely via merlin.Net.Upon review of the transmission, it was noted that the pacemaker was found in backup mode and failure to interrogate.Additionally, the pacemaker exhibited no response to the magnet placement.The pacemaker was explanted and replaced.The patient was in stable condition throughout the procedure.
|
The reported event of inability to interrogate was confirmed.The reported event of pacemaker found in backup mode could not be 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 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 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 high current drain, consistent with moisture damage, depleting the battery prematurely and resulting in the reported events.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.
|