Model Number MN10450-50A |
Device Problem
Migration (4003)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 03/29/2024 |
Event Type
Injury
|
Event Description
|
It was reported that patient was receiving ineffective stimulation and found that the s1 lead had migrated, and 3 of 4 contacts were impeded.As such, surgical intervention is pending to address the issue.
|
|
Manufacturer Narrative
|
B3 - date of event is estimated.
|
|
Manufacturer Narrative
|
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|
|
Event Description
|
Additional information received indicated that patient underwent surgical intervention on (b)(6) 2024 where the s1 lead was explanted and replaced, thereby restoring effective therapy.
|
|
Search Alerts/Recalls
|