BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1190334 · Received October 6, 2008

    Report

    Report Number
    1644487-2008-02416
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 24, 2008
    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

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS NOT ABLE TO FEEL NORMAL AND MAGNET MODE STIMULATION AND WAS EXPERIENCING A RECENT INCREASE IN SEIZURE ACTIVITY, RELATIONSHIP TO PRE-VNS BASELINE UNKNOWN. DIAGNOSTICS WERE PERFORMED FOLLOWING THE ONSET OF THE REPORTED EVENT AND REVEALED NORMAL DEVICE FUNCTION WITH THE END OF SERVICE STATUS SET TO NO. THE PHYSICIAN INCREASED THE OUTPUT CURRENT AND THE PULSE WIDTH AND THE PATIENT SUBSEQUENTLY EXPERIENCED VOICE ALTERATION. THE DEVICE WAS THEN RETURNED TO THE PREVIOUS SETTING. A BATTERY LIFE CALCULATION WAS PERFORMED AND REVEALED THAT THERE WAS APPROXIMATELY 0.43 YEARS REMAINING UNTIL END OF SERVICE IS REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS INC. 102R 016111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention