Model Number 3186 |
Device Problems
Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
|
Event Date 12/24/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer reference number: 3006705815-2021-00105.It was reported that the patient underwent surgical intervention on (b)(6) 2020 wherein a lead was explanted and replaced.The reason for the replacement is unknown.It is unknown which lead was replaced, therefore both are being reported.
|
|
Event Description
|
Additional information received stated that the patient experienced ineffective stimulation.The surgery was performed to achieve better coverage.
|
|
Manufacturer Narrative
|
A4 patient weight added to the report.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
|