BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 2014268 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01777
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 27, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT DEVICE COULD NOT BE INTERROGATED AND WAS IN BACKUP VVI MODE DUE TO A SINGLE FLIPPED BIT IN THE PRODUCT CODE. WHEN THE PRODUCT CODE WAS DOWNLOADED, NORMAL FUNCTION ENSUED. COMPREHENSIVE ELECTRICAL TESTING DID NOT CAUSE THE VVI RESET TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERROGATE OF THE PULSE GENERATOR RESULTED IN A MESSAGE INSTRUCTING THAT A 3510 PROGRAMMER BE USED TO INTERROGATE THE DEVICE. THE PULSE GENERATOR SHOWED NO PACING OR MAGNET RATE. THE PATIENT HAD AN INTRINSIC RATE OF 40 BPM.

    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 Required Intervention