Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Seroma (2069); Ambulation Difficulties (2544)
|
Event Date 05/06/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
During processing of this complaint, attempts were made to obtain complete patient information.
|
|
Event Description
|
It was reported that the patient began experiencing difficulty walking following implantations procedure.As result the patient was taken for emergency surgery where a small seroma was found at the lead site.The seroma was evacuated and the lead repositioned.
|
|
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
|