Device 1 of 4.Reference mfr.Report# 1627487-2018-02876, reference mfr.Report#3006705815-2018-00602, reference mfr.Report# 1627487-2018-03050.It was reported (b)(6) during the scs trial, one of the lead was migrated as the anchor was broken.X-rays confirmed the issue.The patient underwent surgical intervention on (b)(6) 2018 wherein the lead was repositioned and the anchor was explanted and replaced.It is unknown which device is related to the issue.Therefore all the possible devices are being reported.
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