Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880)
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Event Date 12/07/2020 |
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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It was reported that during a trial procedure on (b)(6) 2020, patient experienced headache due to cerebrospinal fluid leakage.The leakage occurred when the physician was attempting to place the lead at l5 space.As a result, the procedure was aborted.
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Event Description
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Additional information received identified that patient's symptoms have resolved.
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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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Search Alerts/Recalls
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