Model Number 3788 |
Device Problems
Nonstandard Device (1420); Device Stops Intermittently (1599); Temperature Problem (3022)
|
Patient Problems
Device Overstimulation of Tissue (1991); Burning Sensation (2146)
|
Event Date 05/25/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Recall: 16271487-12192011-003-r.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
|
|
Event Description
|
Device #1 of 2: reference mfr.Report: 1627487-2016-03105.It was reported the patient was experiencing a burning sensation while recharging and intermittent overstimulation.The patient reports the overstimulation sensation occurs while lying in her bed and driving the car.In addition, the stimulation was intermittent.Follow up information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace the ipg.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.
|
|
Event Description
|
Device #1 of 2: reference mfr.Report: 1627487-2016-03105.
|
|
Manufacturer Narrative
|
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Event Description
|
Device #1 of 2: reference mfr.Report: 1627487-2016-03105.Follow up information identified pocket heating has been resolved.
|
|
Search Alerts/Recalls
|