Related manufacturer reference number: 3006705815-2023-01214, 3006705815-2023-01215, 3006705815-2023-01216, 1627487-2023-00866.It was reported the patient experienced itching everywhere on the body.An allergy test was completed, and the patient reacted to most of the components within the allergy test kit.As such, surgical intervention was undertaken wherein the entire system was explanted.Physician reported the ipg site, lead and anchor site tissue looked normal upon explanting the product.No swelling or fluid was noted at either site.
|
Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight.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.
|