It was reported an infection was present at the ipg and lead site.In turn, the system was explanted, and patient was prescribed oral antibiotics to address the issue.Related manufacturer reference number: 1627487-2022-06763, 1627487-2022-06827, 1627487-2022-06828, 1627487-2022-0682.
|
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.
|