Related manufacturer reference number: 1627487-2023-02384, 3006705815-2023-03165, 3006705815-2023-03166.It was reported the patient had dermatitis at the incision site and later it was determined that the patient had an infection at the lead site.As such, the patient was given oral antibiotics and the patient's scs system was explanted.
|
Date of the event is estimated.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.
|