Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Post Operative Wound Infection (2446)
|
Event Date 12/09/2022 |
Event Type
Injury
|
Event Description
|
Related manufacturer report number 1627487-2022-07112,3006705815-2022-18994,3006705815-2022-18995 and it was reported an infection was present at the anchor site that spread to the leads and battery site.Surgical intervention may occur later to address the issue.
|
|
Manufacturer Narrative
|
Date of event is estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.
|
|
Event Description
|
Surgical intervention was undertaken on (b)(6) 2022 wherein the entire system was explanted.
|
|
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.
|
|
Search Alerts/Recalls
|