Model Number 3664 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 06/18/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The results/method and conclusion codes along with investigation results will be provided in the final report.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 during surgery on (b)(6) 2019 (related manufacturer reference numbers: 1627487-2019-07267, 1627487-2019-07268, 1627487-2019-07266) the patient's ipg would not communicate with external devices.As a result, the ipg was explanted and replaced.Issue resolved.
|
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|