Device 1 of 2.Reference mfr report: 1627487-2015-01413.It was reported the patient has experienced uncomfortable heating of his scs ipg site when charging.A new charging system was sent to the patient to address the issue.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.
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