Catalog Number SD10R-SP05X-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intracranial Hemorrhage (1891)
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Event Date 09/14/2021 |
Event Type
Injury
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Event Description
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A hemorrhage occured during electrode explant procedure.The patient was intubated and an intraventricular drain was placed.Patient was extubated later that day and was reported as "seems to be doing okay".
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Manufacturer Narrative
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Updated 6/13/2022.No further information was received for this complaint and the device was not returned for analysis.As the product was not returned for evaluation the root cause was deemed inconclusive.Per the risk assessment, the calculated occurrence matches the occurrence level present in the risk file and the resulting risk level will remain "acceptable".No further action is needed at this time.
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Event Description
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A hemorrhage occured during electrode explant procedure.The patient was intubated and an intraventricular drain was placed.Patient was extubated later that day and was reported as "seems to be doing okay".
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Search Alerts/Recalls
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