BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 4231221 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18046
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 19, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. AFTER A SOFTWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714739 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1