Model Number 3789 |
Device Problems
Charging Problem (2892); Unintended Movement (3026)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/04/2015 |
Event Type
Injury
|
Event Description
|
It was reported the patient was experiencing intermittent communication between the ipg and the charging system.The ipg was discovered to be tilted inside the pocket.Surgical intervention is pending to address this issue.
|
|
Event Description
|
Follow up information identified the patient underwent surgical intervention to remove and replace the ipg.The ipg was not recharged for an extended length of time while the patient was not receiving stimulation and the physician electively replaced the ipg.
|
|
Manufacturer Narrative
|
Udi (di): (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
|