Device 3 of 3.Reference mfr report: 1627487-2017-00888, reference mfr report: 1627487-2017-00889.The patient had two extensions with the same lot number.It was reported (b)(6) the patient experienced pain and burning sensations at the ipg pocket site as well as at the extension sites on her waist.Stimulation was no longer effective in the targeted pain areas.In addition the patient also received uncomfortable positional stimulation.Reprogramming was unable to resolve the issue and lead diagnostics were normal.The patient underwent surgical intervention where the ipg, penta lead and two extensions were explanted and replaced with a new ipg and penta lead.Ipg pocket site was relocated from the abdominal area to the buttock area, without any extensions.The patient is now receiving effective stimulation and all issues are reported to be resolved.
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