ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number PM2240 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2024 |
Event Type
Injury
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Event Description
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Following the electronics performance indicator (epi), an alert was received by the clinician and device was explanted.Further information was requested, but not yet available.
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Manufacturer Narrative
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Further information was requested, but not yet available.
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Event Description
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New information received noted patient had no consequences.
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Manufacturer Narrative
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The reported event of premature battery depletion was not confirmed.A malfunction based on analysis was found.As received, the device output and telemetry communication were normal.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.The device was tested for a hermeticity breach which was not observed.The device was cut open to enable further testing and battery was operating at the elective replacement indicator (eri) voltage consistent with normal usage.The hybrid circuitry was tested, and the results indicated normal current drain.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.
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Search Alerts/Recalls
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