Device 1 of 2.Reference mfr.Report: 1627487-2015-21353.The patient reported experiencing pocket heating at the ipg site while charging (date of event unknown).A replacement low energy charging system was sent to the patient.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.
|