ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number PM2240 |
Device Problems
Premature Discharge of Battery (1057); 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 09/12/2023 |
Event Type
Injury
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Event Description
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It was reported that patient presented in clinic for routine follow-up.Upon evaluation, it was found that patient's pacemaker was not able to interrogate and there was no magnet response from the pacemaker.No low voltage output and premature battery depletion was also noted.The pacemaker was explanted and replaced.The patient was stable.
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Manufacturer Narrative
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The reported events of no output and no magnet response were confirmed.Premature battery depletion was not confirmed.The device was received with no telemetry communication.Visual inspection of the header attachment area detected an 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.The device was cut open to enable further testing and the battery was found in normal range.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 assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.
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Search Alerts/Recalls
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