BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1150409 · Received September 5, 2008

    Report

    Report Number
    1644487-2008-02178
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT DID NOT RECEIVE ANY EFFICACY FROM VNS THERAPY AND WAS CONSIDERING HAVING IT EXPLANTED. DEVICE DIAGNOSTICS ARE WITHIN NORMAL LIMITS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 016274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other