Section a4: patient weight is estimated.Section b3: date of event is estimated.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.Antibiotics were administered to the patient to address the issue.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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