Model Number CD3369-40Q |
Device Problem
Over-Sensing (1438)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 11/09/2020 |
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 the implantable cardioverter defibrillator was myopotential oversensing.It was unknown how this was discovered.How this was resolved was unknown.The patient condition was unknown.
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Event Description
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New information revealed the over-sensing issue was discovered during an in clinic follow-up.Programming changes were completed to address this issue.There were no patient consequences.
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Search Alerts/Recalls
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