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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It was reported that the implantable cardioverter defibrillator (icd) withheld detection of a ventricular tachycardia (vt) episode that was classified as supra ventricular tachycardia (svt).Review of the monitoring remote transmission showed no p-waves, threshold measurements, or sensing on the right atrial (ra) lead trends since implant.It was noted that the electrograms (egm) showed far field r-wave (ffrw) signals.The ra lead and icd remain in use.No further patient complications have been reported as a result of this event.
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