BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1914038 · Received December 1, 2010

    Report

    Report Number
    1644487-2010-02701
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT HAD DEVELOPED A NEW SEIZURE TYPE AND HAS SUFFERED INJURY WITH FALLING FROM THE SEIZURES. THE REPORTER FEELS THE NEW SEIZURES ARE DUE TO THE VNS BEING ADJUSTED. ATTEMPTS TO THE TREATING NEUROLOGIST FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2355

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR