Model Number PM3212 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device showed premature battery depletion.Abbott technical support was contacted and confirmed that overestimation had occurred during previous follow-ups.Device explant was anticipated to resolve the event.The patient was stable and there were no adverse consequences.
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Event Description
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It was reported that the device showed premature battery depletion.Abbott technical support was contacted and confirmed that overestimation had occurred during previous follow-ups.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
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Manufacturer Narrative
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The reported event of incorrect measurement was not confirmed.Analysis of the device image indicated average current trends were normal and voltage was in a normal range of operation.Analysis of the device image showed that device was set to auto-capture.When the device is set to auto settings the pacing may change based on the requirements of the patient and may cause change in the estimated longevity.Further analysis did not find any anomaly.A longevity assessment was performed determined that the device had appropriate remaining longevity.
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Search Alerts/Recalls
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