Device 2 of 4.Reference mfr report#1627487-2017-03086, reference mfr report#1627487-2017-03087, reference mfr report#1627487-2017-03106.The patient received two extensions with the same lot number.It was reported during permanent implant ((b)(6)) a hematoma was observed at the lead and extension site.Reportedly, the patient was unresponsive after the procedure.Due to infection concern, the scs system was explanted on (b)(6) 2017.Follow-up identified the patient will continue evaluation to confirm the issue.
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