Model Number 3660 |
Device Problems
Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 10/01/2019 |
Event Type
Injury
|
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 results, method, and conclusion codes along with the investigation results will be provided in final report.
|
|
Event Description
|
It was reported the patient's ipg became inoperable following an unrelated surgery.Troubleshooting was unable to recover the device.Surgical intervention may be pending to address the issue.
|
|
Manufacturer Narrative
|
The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Event Description
|
It was reported during follow up the patient underwent surgical intervention during which the ipg was explanted and replaced.Surgical intervention addressed the issue.
|
|
Search Alerts/Recalls
|