Model Number 3788 |
Device Problem
Malposition of Device (2616)
|
Patient Problem
Pain (1994)
|
Event Date 12/08/2014 |
Event Type
Injury
|
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
|
It was reported the patient experienced a fall and following that the patient experienced pain at the ipg site.The patient reported at some point the issue was resolved without intervention.However, the issue recurred.The patient underwent surgical intervention where ipg was replaced and repositioned as the device was tilted in the ipg pocket.
|
|
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.
|
|
Search Alerts/Recalls
|