Device 1 of 4.Ref mfr.Reports: 1627487-2014-03004, 1627487-2014-03005, and 1627487-2014-03306.It was reported the pt has experienced heating while charging, shocking and the inability of her scs ipg to hold a charge despite multiple reprogramming.At this time, it is not clear whether the shocking issue is regarding the scs ipg or the scs leads; therefore, the scs leads are being reported respectively as device 3 and device 4.The scs system was explanted and replaced.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to pts related to heating while charging and raised awareness of this issue to pts.An increase in prior non-reported heating while charging events and other non-reported events was expected.
|