BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYBERONICS

    MDR report key: 597203 · Received April 28, 2005

    Report

    Report Number
    597203
    Event Type
    Other
    Date Received
    April 28, 2005
    Date of Event
    April 19, 2005
    Report Date
    April 28, 2005
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAGAL NERVE STIMULATOR IMPLANTED 2005 MALFUNCTIONED HAD TO BE REPLACED REQUIRING SURGERY IN ABOUT A MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS VAGAL NERVE STIMULATOR LYJ CYBERONICS INC. 102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other