Model Number CD3371-40QC |
Device Problems
Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Heart Failure (2206)
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Event Date 04/14/2020 |
Event Type
Injury
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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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The patient presented in clinic due to inappropriate high voltage therapy delivered for a supraventricular rhythm event.The cause of the event was due to the patient experiencing heart failure.No allegation of malfunction was made against the device and the physician confirmed the device delivered therapy appropriately based upon its programmed settings.The patient was administered a change in heart medication to resolve the event and the patient was in stable condition.
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Search Alerts/Recalls
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