Model Number 3716 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Event Description
|
It was reported the patient's (b)(6) ipg was explanted in 2008 (exact date not provided) due to "failure".No further information regarding the nature of the failure has been provided to the manufacturer.
|
|
Event Description
|
Follow-up information indicated the patient's ipg was unable to communicate with the programmer and was explanted and replaced on (b)(6) 2009.
|
|
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.
|
|
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
|