Model Number 3660 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 05/07/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
|
|
Event Description
|
It was reported ((b)(6)) the patient's ipg would no longer communicate with external devices following a bypass operation.As such, the ipg was inoperable.Surgical intervention may be undertaken to address the issue.
|
|
Event Description
|
Follow-up identified the patient underwent surgical intervention on 28 may 2018 during which the ipg was explanted and replaced.Stimulation was restored following the procedure.
|
|
Search Alerts/Recalls
|