BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1920984 · Received December 9, 2010

    Report

    Report Number
    1644487-2010-02765
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD HIGH IMPEDANCE AT A RECENT APPT. THE DEVICE WAS DISABLED THAT DAY AND PT IS BEING REFERRED FOR SURGERY. PT DENIES ANY TRAUMA. GOOD FAITH ATTEMPTS 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 200419

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR