Related manufacturer reference number: 3006705815-2021-01783.It was reported that during an ipg revision procedure on (b)(6) 2021 [related manufacturer reference number: 3006705815-2021-01611], it was noted the lead and anchor were close to the surface.As a result, surgical intervention was undertaken wherein the lead and anchor were buried deeper.Issue resolved.
|
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. .
|