Related manufacturer reference number: 1627487-2021-16341, related manufacturer reference number: 1627487-2021-16342.It was reported that patient experienced discomfort at the lead site.Company manufacturer examined the location and reported that infection was observed at the lead and exit site.Patient was treated with iv antibiotics and hospitalized.As a result, to address the issue patient¿s system was explanted.Infection has resolved and patient is stable.
|
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.
|