BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1864325 · Received October 7, 2010

    Report

    Report Number
    1644487-2010-02252
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT'S GENERATOR WAS NOTED TO BE MIGRATING FOLLOWING A MOPED ACCIDENT. HOWEVER, THE ACTUAL CAUSE OF THE MIGRATION IS NOT KNOWN. VNS GENERATOR REPOSITIONING SURGERY AND POSSIBLE GENERATOR REPLACEMENT IS PLANNED, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 012407

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention