BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY XL DR

    MDR report key: 2905215 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00806
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 16, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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 ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE ER AFTER EXPERIENCING A SYNCOPAL EPISODE IN THE MORNING. A HEART RATE OF 28 BPM WAS NOTED ON THE ECG. WHEN THE DEVICE WAS INTEROGATED LOSS OF VENTRICULAR CAPTURE WAS NOTED. AFTER THE UPDATE BUTTON WAS PRESSED, THE VENTRICULAR CAPTURE RESUMED. THE DEVICE WAS NEAR ERI WHICH LEAD TO THE DECISION OF EXPLANTING AND REPLACING THE DEVICE ON 10/19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12204 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR