Model Number 6662 |
Device Problem
Wireless Communication Problem (3283)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 08/03/2022 |
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.
|
|
Event Description
|
It was reported the patients ipg became inoperable following an unrelated surgery.Next course of action is undetermined at this time.
|
|
Event Description
|
It was reported the patients ipg became inoperable following an unrelated surgery.Surgical intervention was undertaken on (b)(6) 2022, where the ipg was explanted and replaced.
|
|
Manufacturer Narrative
|
An inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.
|
|
Search Alerts/Recalls
|