BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 4231222 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18047
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    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 PULSE GENERATOR WAS FOUND IN BACKUP VVI MODE AND COULD NOT BE INTERROGATED. IT WAS NOTED THAT A WEEK AGO, THE PATIENT HAD UNDERGONE A COMPUTED TOMOGRAPHY SCAN. AFTER DEVICE FIRMWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715280 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1