BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1230886 · Received November 6, 2008

    Report

    Report Number
    1644487-2008-02681
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MANUFACTURER'S IMPLANT CARD WAS RECEIVED INDICATING THAT A VNS PT HAD UNDERGONE REVISION SURGERY DUE TO A LEAD DISCONTINUITY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1545

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR