Model Number 3662 |
Device Problem
Wireless Communication Problem (3283)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 03/29/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Event Description
|
It was reported the patient's ipg failed to establish communication with external devices.Patient had an unrelated surgery on (b)(6) 2021 where ipg was set into surgery mode.Patient also had a car accident on (b)(6) 2021.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.In turn, surgical intervention may be pending to address the issue.
|
|
Manufacturer Narrative
|
The event of inoperable ipg was reported to abbott.No intervention is being planned at this time.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.
|
|
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.
|
|
Event Description
|
Additional information indicated that a surgical intervention occurred wherein the ipg was explanted and replaced to address the issue.
|
|
Search Alerts/Recalls
|