Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Post Operative Wound Infection (2446)
|
Event Date 12/22/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2024-00531, 3006705815-2024-00831, 1627487-2024-00533.It was reported the patient's system was explanted due to an infection at the lead sites.
|
|
Manufacturer Narrative
|
A patient's system was explanted due to an infection at the lead sites.The infection resolved.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
|
|
Event Description
|
Additional information received indicates the infection has resolved.
|
|
Search Alerts/Recalls
|