Related manufacturer reference number: 1627487-2022-02163, 1627487-2022-02164, 1627487-2022-02165, 1627487-2022-02168, 1627487-2022-02169.It was reported the patient experienced an infection at the lead site.Surgical intervention took place wherein the system was explanted to address the issue.Patient was prescribed oral antibiotics.
|
An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.The patient received oral antibiotics and the infection has since been resolved.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection is yet to be substantiated.
|