Sc-2218-50 (sn (b)(4)): device evaluation indicated that the lead complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 26 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed 6 cables were fractured (electrodes 1-3, 5, 6,8) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-2218-50 (sn (b)(4)): device evaluation indicated that the lead complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 26 cm from the distal end.A cable is exposed at 7 cm from proximal end.X-ray inspection confirmed 7 cables were fractured (electrodes 1-4, 5, 6-8) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-4316 (ln 18086905): device evaluation indicated that the clik anchor eyelets were torn; there was no missing silicone material.Sc-4316 (ln:18086905) the device evaluation indicated that the eyelets were torn, and there was no missing silicone material.
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