Model Number CD3371-40QC |
Device Problem
Over-Sensing (1438)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 01/15/2020 |
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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Related manufacturer reference number: 2017865-2020-00920.It was reported that the cardiac resynchronization therapy defibrillator and left ventricular lead exhibited continued phrenic nerve stimulation, despite multiple vector testing, and non-sustained oversensing episodes.No intervention was performed, and the device and lead remained implanted.The patient was stable.
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Event Description
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Additional information received noted that the patient followed up in clinic on (b)(6) 2020.Upon investigation, it was noted there were a total of 49 right ventricular over sensing episodes recorded by the defibrillator.Programming changes were recommended but the attending doctor did not want to make these changes as he felt it may not be sensitive enough to detect ventricular fibrillation.The left ventricular lead was tested for the presence of phrenic nerve stimulation.The phrenic nerve stimulation was not reproduced.It was suspected the patient was experiencing the phrenic nerve stimulation during the auto capture test, so the device was reprogrammed.The patient was stable and would be monitored.
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Search Alerts/Recalls
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