Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 09/04/2023 |
Event Type
Injury
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Event Description
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After an atrial fibrillation procedure, on the same day, the patient experienced a stroke that was diagnosed with an mri.There were no issues noted during the procedure and the patient is currently stable.It is unknown what caused the stroke.
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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.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported stroke could not be conclusively determined.
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Event Description
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After an atrial fibrillation procedure, on the same day, the patient experienced a stroke that was diagnosed with an mri.There were no issues noted during the procedure.The patient is currently stable and it is unknown what caused the stroke.
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Search Alerts/Recalls
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