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Model Number PM2152 |
Device Problems
Failure to Interrogate (1332); No Pacing (3268)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
Injury
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Event Description
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It was reported that the device was not providing pacing support and was unable to be interrogated via inductive telemetry.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.
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Manufacturer Narrative
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The reported events of no output and no inductive telemetry 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 at normal level.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.Hybrid circuitry was tested, and the results indicated normal current drain.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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Search Alerts/Recalls
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