Related manufacturer report number: 3006705815-2021-05920, 3006705815-2021-05921, 1627487-2021-18587 it was reported the patient had an infection at the lead site.As a result, the patient underwent surgical intervention during which the system was explanted.
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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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