BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 1073280 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02079
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 9, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN ELECTRICAL MEASUREMENTS FOUND INCORRECT PACING RATE, SENSING ANOMALIES, AND MEASURED DATA ANOMALIES. THE HYBRID MANUFACTURER WAS UNABLE TO REPRODUCE THE ANOMALIES AT THE HYBRID LEVEL, THEREFORE THE REASON FOR THE ANOMALIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING INTERROGATION THE DEVICE STOPPED PACING.

    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