Related manufacturer reference number 3006705815-2021-06181, 3006705815-2021-06182, 3006705815-2021-06183, 1627487-2021-18883.It was reported the patient had an infection at the ipg site and lead site.In turn, the patient underwent surgical intervention wherein the entire system was explanted, and the patient was placed on antibiotics to address the issue.
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Date of event: date of 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.
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