Device 2 of 2.Reference mfr.Report#: 1627487-2018-03495.It was reported the patient experienced heating at the ipg site while recharging.As such, the patient underwent surgical intervention wherein the scs system was removed in 2013 (exact date is unknown).On (b)(6) 2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.
|