BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERLIN PROGRAMMER

    MDR report key: 3802511 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13742
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    KRG
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 PROGRAMMER EXHIBITED A SHOCK ON THE SCREEN AND STOPPED WORKING. THE DEVICE WAS NO LONGER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281316 MERLIN PROGRAMMER PACEMAKER PROGRAMMER KRG ST. JUDE MEDICAL, INC., CRMD 3650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1