It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) system the patient experienced septic shock. additionally, the right atrial (ra) lead appeared to exhibit potential under sensing triggering device classified false termination of atrial tachycardia (at)/atrial fibrillation (af) event(s) at times, and under sensing that appeared to result in inappropriate atrial pacing at times. the crt-d system remains in use. no further patient complications have been reported as a result of this event.
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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