Model Number 3788 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
Burning Sensation (2146)
|
Event Date 06/18/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Event date is estimated.Further information requested but not available.The results/method and conclusion codes along with the investigation results will be provided in the final report.
|
|
Event Description
|
It was reported patient experienced burring sensation at the pocket site when charging for long.Surgical intervention may be addressed to address this issue.
|
|
Event Description
|
Additional information indicates surgical intervention was undertaken on (b)(6) 2020 wherein the system was explanted.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
|