Model Number 3662 |
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 Type
Injury
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Manufacturer Narrative
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The results, method, and conclusion codes along with the investigation results will be provided in final report.
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Event Description
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Related manufacturer reference number: 1627487-2020-00556.Related manufacturer reference number: 1627487-2020-00557.It was reported the patient was admitted to the hospital with a suspected stroke.The patient lost feeling on their right side.
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Manufacturer Narrative
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A patient was admitted to the hospital with a suspected stroke was reported to abbott.It was determined the patient lost feeling in their right side.No intervention is planned.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 event could not be conclusively determined.
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Event Description
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It was reported during follow up the stroke was caused by an aneurysm.The physician believes the event to be unrelated to the system.Patient has regained feeling with the help of physical therapy.
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Search Alerts/Recalls
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