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Model Number MN10350-50A |
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 11/13/2020 |
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 during a drg trial procedure on (b)(6) 2020 a cerebrospinal fluid (csf) leak occurred while attempting to place a lead.In turn, the lead was not implanted and a blood patch was administered.Postoperatively, the patient indicated having a headache and was instructed to consume caffeine and lay flat.Follow-up information indicates the patient's headaches have subsided.
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Search Alerts/Recalls
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