BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 1222919 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03269
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    July 25, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE DEVICE AS RECEIVED COULD BE INTERROGATED AND WAS IN BACKUP VVI MODE, DUE TO NONMASKABLE INTERRUPTION. NORMAL BACKUP VVI CHARACTERISTICS WERE MEASURED. AFTER DOWNLOADING THE PRODUCT CODE, NORMAL DEVICE FUNCTION ENSUED. THE CAUSE OF THE BACKUP VVI COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR HAD NO OUTPUT AND WOULD NOT INTERROGATE WHEN IT WAS CONNECTED.

    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