BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3901118 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12603
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 6, 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
    OH, US
    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 AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR FOLLOW UP. PATIENT HAD EPISODES OF NON SUSTAINED LEAD NOISE. REVIEW OF THE EGM REVEALED COMPETITIVE ATRIAL PACING BLANKING CONDUCTED VENTRICULAR EVENTS. PROGRAMMING CHANGES WERE MADE. PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379610 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR