BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1083428 · Received July 28, 2008

    Report

    Report Number
    1644487-2008-01725
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PT "WAS NOT HAVING GOOD CONTROL OVER THEIR SEIZURES." FURTHER INFO WAS RECEIVED THAT REPORTED THE PT'S SEIZURES WERE ABOVE THEIR PRE VNS SEIZURE RATE. SYSTEM DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS. THE NORMAL MODE TEST SHOWED THE GENERATOR IS DELIVERING THE CURRENT BUT AT ITS LIMIT TO DO SO WITH THE REMAINING BATTERY LIFE. SETTING CHANGES WERE MADE AND THE GENERATOR WAS ABLE TO DELIVER ITS NEW PROGRAMMED SETTINGS. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADD'L INFO. NO FURTHER INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016999

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other