During an in clinic follow up, upon attempting to interrogate the device using inductive telemetry an intermittent connection was noted.Additionally, when stimulating the device with a magnet, intermittent pacing was also noted.The device was explanted and replaced to resolve the event.The patient was stable.
|
The reported event of interrogation issues was confirmed.The reported event of pacing issues was not confirmed.The device was received with unstable telemetry communication.Device turned into bvvi during analysis.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 at normal levels with signs of rapid depletion.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.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the zenex, assurity, enduritylaser adhesion preparation advisory issued by abbott on 20 july 2022 for a subset of devices distributed and implanted outside of the united states.
|