BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 3920418 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14016
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    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 DURING A ROUTINE FOLLOW-UP, THE PULSE GENERATOR WAS FOUND TO BE IN BACKUP MODE. A SOFTWARE DOWNLOAD SUCCESSFULLY RESTORED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397435 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR