Device 1 of 2; reference mfr report: 1627487-2015-01284.It was reported the patient complained he experienced pocket heating while charging his scs ipg.The patient stated he experienced a burning sensation on the skin and stopped using the scs system sometime after the heating started happening.A replacement charging system was sent to the patient to address the issue.On 08/01/2012 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.
|