Device 4 of 4 reference mfr.Report#: 1627487-2018-06123 reference mfr.Report#: 3006705815-2018-01533 reference mfr.Report#: 1627487-2018-06124 it was reported the patient's leads had pulled out from the ipg header.X-rays confirmed the issue.As such, the patient was without stimulation.In turn, the patient underwent surgical intervention on (b)(6) 2018, wherein the extension was explanted and replaced with new ones.It was noted an additional extension was placed to provide maximum flexibility.The ipg is now connected via the new extensions.Reportedly, effective therapy was restored following the procedure.
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