Related manufacturer reference number 1627487-2020-21182, 1627487-2020-21183, 1627487-2020-21184, 1627487-2020-21185, 1627487-2020-21186, 1627487-2020-21187.It was reported that patient experienced ineffective stimulation.As a result, patient underwent surgical intervention wherein the entire scs system was explanted.
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During processing of this complaint, attempts were made to obtain patient weight.Further information was requested but not received.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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