Related manufacturer report numbers 1627487-2022-01924, 1627487-2022-01925, 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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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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