BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1910684 · Received November 22, 2010

    Report

    Report Number
    1644487-2010-02648
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED INDICATED A VNS PATIENT WAS HAVING INCREASED SEIZURES, AND THAT THE VNS WAS NOT AT END OF SERVICE. THE PATIENT IS CURRENTLY HAVING TESTING TO DETERMINE THE ETIOLOGY OF THE SEIZURE INCREASE. THE VNS IS WORKING PROPERLY PER THE REPORTER. THE LEVEL OF THE SEIZURE INCREASE RELATIVE TO THE PRE-VNS SEIZURE BASELINE LEVEL IS UNK. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011190

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention