Model Number 3771 |
Device Problem
Device Stops Intermittently (1599)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 12/21/2015 |
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.(b)(4).
|
|
Event Description
|
It was reported the patient's ipg randomly powers off without prompting.Subsequently, surgical intervention was undertaken during which time the ipg was explanted and replaced.Stimulation was restored postoperatively.The issue is resolved.
|
|
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
|