Continuation of d10: 6935m55 lead, implanted: on (b)(6) 2019.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) feature designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of a supra ventricular tachycardia (svt) origin possibly inappropriately withheld therapy for a ventricular tachycardia (vt) episode that the crt-d classified as svt.Additionally, it was noted that the patient received inappropriate anti-tachycardia pacing and inappropriate high voltage therapy for svt that the crt-d detected as fast ventricular tachycardia (fvt).Lastly, it was noted that the patient experienced shortness of breath.The crt-d remains in use.No further patient complications have been reported as a result of this event.
|