BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 1896559 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05330
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 20, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 A REVIEW OF THE RHYTHM STRIP REVEALED THAT THE PULSE GENERATOR WAS NOT CAPTURING THE ATRIUM BUT WAS ALLOWING THE NATURAL SINUS RATE TO COME IN UNDERNEATH THE PACING. THE DEVICE WAS PROGRAMMED TO DDI MODE. THE PATIENT HAS FREQUENT HIGH ATRIAL RATES AND IS NOT SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR