Related manufacturer reference number: 3006705815-2023-01312, 3006705815-2023-01313, 1627487-2023-01241 it was reported an infection was suspected at the lead site.As such, the physician removed a portion of the leads.The leads were cut (related manufacturer reference number: 3006705815-2023-01315 and 3006705815-2023-01314).Cultures determined that there was not an infection at the site as suspected.
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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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