Related manufacturer reference number 3006705815-2023-06144.It was reported an infection was present at the lead site.As a result, patient was given iv antibiotics.Several days after the iv antibiotics were given the infection had not resolved and the system was explanted to address the issue.Reportedly, the infection has resolved.
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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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