Related manufacturer reference number: 3006705815-2023-04785, 3006705815-2023-04786, 3006705815-2023-04787, 1627487-2023-03646.It was reported that patient experienced an infection at the ipg and both leads.Surgical intervention was undertaken wherein the system was explanted at an unknown date.A new scs system was implanted at a later date.
|
An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.
|