Related manufacturer reference number: 3006705815-2022-17210, related manufacturer reference number: 3006705815-2022-17211, related manufacturer reference number: 1627487-2022-05444.It was reported that the patient experienced infection at the incision sites of the leads.The wound was very sensitive, hot to touch, swollen and red.As such, surgical intervention took place on (b)(6) 2022 wherein the entire system was explanted to address the infection.Reportedly, the infection is being treated with oral antibiotics.
|
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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.
|