Model Number 3799 |
Device Problem
Temperature Problem (3022)
|
Patient Problems
Hyperthermia (1909); Burning Sensation (2146); Discomfort (2330)
|
Event Date 06/28/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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
|
It was reported the patient ((b)(6)) experienced discomfort due to pocket heating while recharging.Troubleshooting was tried to no avail.A replacement charger was sent to the patient which resolved the issue at time, however the issue recurred.It was also reported the patient's ipg appeared to be shallow.The patient has malignant hyperthermia which the physician has suspected to be a cause of the heating.Consequently, the ipg was explanted.
|
|
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.
|
|
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.
|
|
Search Alerts/Recalls
|