Related manufacturer reference number: (b)(4).Related manufacturer reference number: (b)(4).Related manufacturer reference number: (b)(4).Related manufacturer reference number: (b)(4).It was reported that the patient experienced swelling at the lead incision site.It was noted that the lead and ipg site both had fluid filled.Ct scan, ultrasound and blood test did not show any sign of infection.Additional blood test was done and the physician elected to explant the system due to risk of infection.As such, the entire system was explanted on (b)(6) 2023 to address the issue.
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A patient had their system explanted due to a suspected infection was reported to abbott.It was determined the patient had swelling/fluid around incision site.The physician observed that the lead site and battery site both filled with fluid.Patient has not been unwell, reports some sweating but has not had any other infection symptoms.Patient sent to the emergency room to have ct scan, ultrasound and blood tests completed.As a result, the physician elected to explant the entire system due to risk of infection.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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