Related manufacturer report numbers 1627487-2024-07712, 1627487-2024-07713.It was reported that the patient was experiencing discomfort at ipg site and ineffective therapy.X-ray imaging revealed lead migration.As a result, surgical intervention was undertaken on (b)(6) 2024 where the patient's left l5 and s1 leads were replaced as well as the patient's ipg was repositioned to the right flank to address the issue.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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