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.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.
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Related manufacturer report number: 3006705815-2020-32098, 3006705815-2020-32099, 1627487-2020-48750, 3006705815-2020-33171.It was reported after an unrelated lead replacement procedure (manufacturer report number: 3006705815-2020-31261), the incision did not heal well.The wound was cleaned, but an infection was later found at the ipg and lead site.As a result, the patient underwent surgical intervention during which the system was explanted.The infection was later cleared.
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