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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Related manufacturer reference number 3006705815-2022-13803, 3006705815-2022-13804, 1627487-2022-02216.It was reported that patient experienced infection at the lead site.As a result, surgical intervention was undertaken wherein the entire system was explanted to address the issue.
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