Model Number 3660 |
Device Problem
Wireless Communication Problem (3283)
|
Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
|
Event Date 07/13/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.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 that the patient's ipg became inoperable after an unrelated procedure where the ipg was not placed in surgery mode.
|
|
Manufacturer Narrative
|
During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.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.
|
|
Event Description
|
Additional information received indicates that the patient may undergo surgical intervention.
|
|
Search Alerts/Recalls
|