Model Number PM3562 |
Device Problem
Pacemaker Found in Back-Up Mode (1440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
malfunction
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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 a device check revealed a pacemaker was found in back up mode.The device was not used.
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Manufacturer Narrative
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The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a reset error had occurred and caused the device to revert to backup mode.Backup operation was reproduced at cold temperature, which is consistent with u2 xena ic cold temperature sensitivity anomaly.
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Search Alerts/Recalls
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