BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARQUIS INSYNC II

    MDR report key: 644990 · Received October 17, 2005

    Report

    Report Number
    644990
    Event Type
    Other
    Date Received
    October 17, 2005
    Date of Event
    October 13, 2005
    Report Date
    October 17, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME INTO THE EMERGENCY ROOM COMPLAINING OF SHORTNESS OF BREATH. ICD SHOWED DISCHARGE WITH VENTRICULAR TACHYCARDIA AND V-FIB WITH RATE OF 240 - 160 PER MINUTE. PATIENT HAS HISTORY OF CONGESTIVE HEART FAILURE WITH SEVERE ISCHEMIC CARDIOMYOPATHY. IN VIEW OF THE PATIENT'S HISTORY, THIS RECALLED ICD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS INSYNC II AICD LWS MEDTRONIC, INC. 7289 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *