BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3884674 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12177
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP WITH FAR FIELD R-WAVE OVERSENSING ON THE ATRIAL CHANNEL. THE DEVICE WAS FOUND TO HAVE SEVERAL AUTOMODE SWITCH EPISODES. PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE AFTER THE EVENT. REMOTE MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360535 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR MDT LEAD 4076, BBL798293V