BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3943894 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13516
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT RECEIVED A TRANSMISSION FOR BACK UP VVI VIA MERLIN.NET. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE BACKUP VVI TRANSMISSION WAS INAPPROPRIATE. THE DEVICE WAS NOT FOUND IN BACK UP VVI. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421794 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR