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 reference number: 1627487-2021-18168.It was reported that patient experienced pain near the anchor site of their scs system.In turn, surgical intervention was undertaken on (b)(6) 2021 wherein hardened scar tissue was removed and anchors were sutured deeper in the tissue.Therapy was established post operatively and issue resolved, reportedly.
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