BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN MODEL 102

    MDR report key: 1111759 · Received August 12, 2008

    Report

    Report Number
    1644487-2008-01879
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT "THE VNS HAD WORKED FAIRLY WELL, BUT THAT ABOUT 6 MONTHS AGO, HER SON BEGAN EXPERIENCING MORE SEIZURES AND AN INCREASE IN LETHARGY. MEDICATIONS WERE INCREASED, BUT THAT THE VNS WAS NOT INTERROGATED." IT IS UNKNOWN IF THE PT'S REPORTED SEIZURES WERE ABOVE THEIR PRE VNS SEIZURE RATE. THE PT HAD THEIR GENERATOR REPLACED AND IT WAS SENT TO THE MFR FOR ANALYSIS. THE GENERATOR MET MFR TESTING SPECIFICATIONS AND WAS NOT AT END OF BATTERY LIFE. NO MALFUNCTIONS OR ANOMALIES THAT WOULD HAVE AFFECTED DEVICE PERFORMANCE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN MODEL 102 LYJ CYBERONICS, INC. 102 8125

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R