Related manufacturer reference number: (b)(4).It was reported that the patient experienced pain at the lead incision site.Diagnostic revealed that the patient experienced a staph infection at the lead incision site.As such, surgical intervention took place on (b)(6) 2023, wherein the entire system was explanted to address the issue.Reportedly, the patient was on iv and finishing with oral medication to treat the infection.
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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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