BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 1896603 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05324
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI). MEASURED DATA WAS 2.51 V, 3.0 UA, LESS THAN 1.0 KOHM. IMPEDANCE MEASUREMENTS WERE REPORTED LOW. THE ESTIMATED REMAINING LONGEVITY WAS CALCULATED TO 2.1 YEARS ALTHOUGH THE DEVICE ESTIMATED 4.1 YEARS FROM IMPLANT TO ERI. THE DEVICE WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE BLACK MARKS WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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 5810

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention