|
Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Post Operative Wound Infection (2446)
|
Event Date 12/08/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient had an infection at the s1 lead site.In turn, the patient underwent surgical intervention wherein the system was explanted.
|
|
Manufacturer Narrative
|
B3-date of event is estimated.Additional components potentially involved in the event include: common device name: drg lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), lot: 8860739.
|
|
Manufacturer Narrative
|
An event of infection was reported to abbott.It was conveyed that the infection originates at the s1 lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection remains unknown.
|
|
Search Alerts/Recalls
|
|
|