BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 4153547 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16333
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LV CAP CONFIRM TREND SHOWED MULTIPLE OUT OF RANGE MEASUREMENTS SINCE IMPLANT. REVIEW OF THE MERLIN.NET TRANSMISSION SHOWED NORMAL LEAD IMPEDANCE MEASUREMENTS AND SUCCESSFUL CAPTURE AT HIGH OUTPUT. THE PATIENT WAS SCHEDULED FOR FURTHER LEAD EVALUATION. MEDICATIONS WERE ADJUSTED AND PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632225 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR