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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 (1880)
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Event Date 03/23/2022 |
Event Type
Injury
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Event Description
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Related manufacturer report numbers 1627487-2022-01923, 1627487-2022-01925 and 1627487-2022-01926.It was reported that, following the placement of the trial leads, the patient began experiencing headaches.It was found that a csf leak had occurred.Patient was instructed to rest and drink caffeine.The csf leak has since 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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