Device 2 of 4: reference mfr.Report# 1627487-2016-01290, reference mfr.Report# 1627487-2016-01295, reference mfr.Report# 1627487-2016-01297.It was reported the patient experienced infection at the ipg site (date of event unknown).The patient was prescribed oral antibiotics.Further follow up identified the ipg site appeared red and tender.The redness radiated to the leads too.The patient underwent surgical intervention on (b)(6) 2016 where the scs system was explanted.The cultures taken resulted in negative for infection.The patient received four leads of the same lot number (model: 3146; lot # 171366).Additionally, the patient has three extensions.Two of them are from same lot number (model: 3341; lot # 115142).
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