Manufacturer reference number:1627487-2024-07410.It was reported that the patient's scs anchor was protruding and became painful.As a result, surgical intervention was undertaken on (b)(6) 2024 where the patient's anchors were replaced to address the issue.Additionally, the leads and ipg were electively replaced.Effective therapy restored post op.
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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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