Device 2 of 3.Reference mfr report # 1627487-2018-03095,1627487-2018-03521.It was reported the patient experienced ineffective stimulation from the scs system following an ipg replacement surgery (reference report mfr# 1627487-2018-02391) on (b)(6) 2018.Multiple trouble shooting attempts were made which did not resolve the issue.Diagnostic testing concluded that multiple contacts reflected high and low impedance readings.X-rays revealed the leads had pulled out of the ipg header.As a result, the patient underwent surgical intervention on (b)(6) 2018, wherein the scs system was explanted.
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