BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERONICS, INC

    MDR report key: 640424 · Received October 10, 2005

    Report

    Report Number
    640424
    Event Type
    Malfunction
    Date Received
    October 10, 2005
    Date of Event
    December 27, 2004
    Report Date
    January 10, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRACKED VAGAL NERVE STIMULATOR LEAD; POSSIBLE BATTERY DEPLETION DUE TO CRACKED LEAD; BOTH COMPONENTS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS, INC VAGAL NERVE STIMULATOR LEAD LYJ CYBERONICS, INC. 102R *
    2 CYBERONICS, INC VAGAL NERVE STIMULATOR LEAD LYJ CYBERONICS, INC. 300-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR