The date of event is estimated.Based on the information provided a product 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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It was reported that the patient's ipg was superficial and was causing discomfort at ipg site.As a result, surgical intervention was undertaken on (b)(6) 2024 where the patient's ipg was repositioned to the buttock region to address the issue.Reportedly, effective therapy restored post op.
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