BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2193123 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01670
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS HAVING MORE SEIZURES. PER PHYSICIAN, IT WAS DISCOVERED HIS DRUG LEVELS ARE VERY LOW. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200882

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other