BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1910683 · Received November 22, 2010

    Report

    Report Number
    1644487-2010-02642
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT WAS HOSPITALIZED FOR INCREASED SEIZURES SHORTLY AFTER BEING IMPLANTED WITH THE VNS DEVICE. THE VNS WAS NOT ENABLED AT SURGERY. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention