BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1150408 · Received September 5, 2008

    Report

    Report Number
    1644487-2008-02171
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT WAS SCHEDULED TO HAVE A GENERATOR REPOSITION SURGERY BECAUSE THE GENERATOR MOVES WHILE THE PATIENT IS SWIMMING. THE MOVEMENT CAUSES THE PATIENT DISCOMFORT. 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 016999

    Patients

    Seq Age Sex Outcome Treatment
    1 Other