BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3943844 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13485
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 2, 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
    NY, 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 THAT VIA MERLIN.NET THE DEVICE WAS FOUND TO BE IN BACKUP BVVI. PATIENT PRESENTED IN CLINIC; A SOFTWARE DOWNLOAD WAS SUCCESSFULLY PERFORMED AND THE DEVICE WAS RESTORED TO NORMAL OPERATION. PATIENT WILL CONTINUED TO BE MONITORED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421452 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR