Model Number PM3562 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the patient presented to the clinic for a follow up.Interrogation showed their pacemaker had reached elective replacement early with suspected premature battery depletion.The physician explanted and replaced the pacemaker.There were no patient consequences throughout.
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Manufacturer Narrative
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Final analysis found the reported premature battery depletion was confirmed in the laboratory.High current was observed during bench testing and was traced to the hybrid circuitry.The cause of the premature battery depletion was due to excess current on the hybrid.
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Search Alerts/Recalls
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