Related manufacturer reference number: 3006705815-2019-04978, 3006705815-2019-04979, 3006705815-2019-04980, 1627487-2019-14089.It was reported by the patient on (b)(6) 2019, that the patient had an infection and had their full system explanted 6 to 7 months ago at an unknown time with an abbott rep not present.The patient had a new system implanted on (b)(6) 2019.
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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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