Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)
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Event Date 08/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 3006705815-2020-31091.It was reported that the patient experienced a cerebrospinal fluid (csf) leak during a perm implant on (b)(6) 2020.The physician performed a blood patch intra-operatively.Post-operatively, the patient reported a slight headache that resolved on its own.
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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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Search Alerts/Recalls
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