Related manufacturer reference number: 3006705815-2024-01661, 1627487-2024-07276, 1627487-2024-07277 it was reported the patient experienced an infection at both the ipg and lead sites.Surgical intervention took place wherein the system was explanted.Infection has resolved.
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Date of event is estimated.A patient had their system explanted due to infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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