Device 1 of 2.Reference mfr report: 1627487-2015-01419.It was reported the patient experienced uncomfortable warmth at her ipg site when she charged.The patient stated sometimes the warmth would be uncomfortable enough for her to stop charging.A replacement 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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