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Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 01/10/2024 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .
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Event Description
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It was reported that the patient experienced a cerebrospinal fluid leak that occurred during a permanent implant procedure on (b)(6) 2024.As a result, a blood patch was performed, and the procedure was aborted.The patient reported a headache; however, the patient's symptoms have since been resolved.
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Search Alerts/Recalls
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