BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1844784 · Received September 23, 2010

    Report

    Report Number
    1644487-2010-02162
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO INTERROGATE THE PT'S DEVICE. THE PT REPORTED BEING UNABLE TO FEEL MAGNET STIMULATION AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2010. THE PT HAS NOT HAD ANY OTHER ADVERSE EVENTS. PT HAS BEEN REFERRED FOR REVISION SURGERY, BUT IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 014007

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR