Related manufacturer reference number: 1627487-2024-00824 it was reported that during a lead replacement procedure on 26 january 2024 [related manufacturer reference number:1627487-2023-05752 and 1627487-2023-05753], patient had a csf leak.As a result, a blood patch was performed to address the issue, patient is stable.
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The results of the investigation are inconclusive 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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