Related manufacturer reference numbers: 1627487-2020-31960, 1627487-2020-31961, 1627487-2020-31963.It was reported that the patient experienced ineffective stimulation since implant.Reprogramming was attempted, but did not restore effective stimulation.In turn, surgical intervention was undertaken on (b)(6) 2016, wherein the entire scs system was explanted.Post-operatively, it was discovered the paddle lead had pulled out.It is unknown if the lead pulled out from the extensions or the ipg, therefore all devices are being reported.
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During processing of this complaint, attempts were made to obtain complete patient information.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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