Device 2 of 3.Reference mfr report#1627487-2019-01155, reference mfr report#1627487-2019-01156.It was reported that during the scs explant procedure, on (b)(6) 2019,(reference mfr report #¿s 1627487-2019-01125, 1627487-2019-01158, 1627487-2019-01159, 1627487-2019-00969, 1627487-2019-01160, 1627487-2019-01161) the swift lock anchor was broken in half when the physician removed the s8 lead and the broken piece was stuck in the epidural space.As a result, the anchor was explanted.It is unknown which anchor is liable therefore all the implanted anchors are made reportable.
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