Date of event is estimated.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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Related manufacturer report number: 1627487-2024-07393, 3006705815-2024-01798.It was reported that the patient experienced pain at the anchor site and pain at the ipg site.It was also reported that the patient has had some weight loss.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the scs was explanted and replaced to address the issue.
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