BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL

    MDR report key: 1181594 · Received September 25, 2008

    Report

    Report Number
    1644487-2008-02347
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PATIENT HAD BEEN EXPLANTED FOR PAIN IN THE CHEST AND NECK AREA WITH VNS THERAPY. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other