Related manufacturer reference number: 3006705815-2023-06601, related manufacturer reference number: 3006705815-2023-06602, related manufacturer reference number: 3006705815-2023-06603, and related manufacturer reference number: 1627487-2023-04908.It was reported that the patient is experiencing pain at the ipg site, lead site and anchor site.Additional information received indicates patient both anchors attributed to the pain at anchor site.Surgical intervention took place on (b)(6) 2023 wherein the leads and anchors were explanted and replaced with new leads and anchors.Additionally, the ipg was repositioned higher to address the issue.Reportedly, the pain at the implant sites has resolved post op.
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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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