Model Number PM3562 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/23/2021 |
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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During a remote follow-up, myopotentials oversensing and inappropriate mode switch were noted on the device.No intervention was performed at this time.The patient was stable and will continue to be monitored.
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Event Description
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Additional information was received that the event was resolved by reprogramming the device.The patient was in stable condition.
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Search Alerts/Recalls
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