BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 1896558 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05328
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    THE PACEMAKER DEPENDENT PATIENT PRESENTED FOR AN ELECTIVE UPGRADE TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. BEFORE THE REPLACEMENT PROCEDURE, THE PULSE GENERATOR EXHIBITED NORMAL FUNCTION. THE PHYSICIAN USED CAUTERY IN THE POCKET AREA, AFTER WHICH THE DEVICE EXHIBITED NO PACED RHYTHM. AFTER A PERIOD OF TIME, PACING RESUMED. IT WAS SUSPECTED THAT CAUTERY WAS TOO CLOSE TO THE DEVICE, CAUSING PACING INHIBITION. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 66 YR Required Intervention