Model Number PM3562 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
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 that the patient presented with an alert for biv pacing less than the limit.It was noted that trail noise episodes were recorded.Upon reviewing egms it was suggested that fine af had triggered the atrial noise episode and therefore these are not genuine noise events.The patient was stable and is being monitored.
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Event Description
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New information states that there was a directalert for biv% pacing.The report had recorded 17xatrial noise reversions.Egms if fact suggest fine af not genuine noise.
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Search Alerts/Recalls
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