The event of an ipg pocket revision was reported to abbott.The ipg pocket was revised and the ipg placed deeper and more proximal.During the procedure, the s1 lead had pulled out of the foremen.The s1 lead was removed, and a new lead was placed.Therapy was restored after the procedure.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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Related manufacturer report number:1627487-2024-00356.It was reported that the patient's ipg migrated and was causing pain.It was also noted that the patient's s1 lead migrated out of the foramen.Surgical intervention was undertaken on (b)(6) 2024 wherein the patient's ipg was repositioned and the patient's migrated s1 lead was explanted, replaced, and therapy was restored.
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