Model Number 3660 |
Device Problem
Battery Problem (2885)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 07/01/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Event Description
|
It was reported the patient's ipg became inoperable.As a result, the patient may undergo surgical intervention to address the issue.
|
|
Event Description
|
Additional information received indicates that the patient underwent surgical intervention during which the ipg was explanted and replaced with no complications.
|
|
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 received indicates that no migration was observed.Only one lead was fractured.The patient underwent surgical intervention during which the system was explanted and replaced.Effective therapy was established post-operatively.
|
|
Manufacturer Narrative
|
Correction: additional report 2 should not have been submitted, as it was created and submitted in error.
|
|
Search Alerts/Recalls
|