Device 6 of 7; reference mfr.Report#: 3006705815-2018-01866, reference mfr.Report#: 1627487-2018-07433, reference mfr.Report#: 1627487-2018-07434, reference mfr.Report#: 1627487-2018-07435, reference mfr.Report#: 1627487-2018-07436, reference mfr.Report#: 1627487-2018-07450.The patient has an scs system for off-label use.It was reported scar tissue was present at the patient's lead and ipg site.As a result, the patient underwent surgical intervention on (b)(6) 2018.During the procedure, scar tissue was removed from both sites and the ipg was repositioned.Surgical intervention addressed the issue.
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