BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1130843 · Received August 19, 2008

    Report

    Report Number
    1644487-2008-01936
    Event Type
    Injury
    Date Received
    August 19, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT THE VNS PT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. THE PHYSICIAN DECIDED TO REPLACE THE GENERATOR. THE DR WAS ABLE TO ESTABLISH COMMUNICATION WITH THE GENERATOR AND THE GENERATOR WAS NOT AT END OF SVC. HE ALSO INFORMED US THAT THE PT HAD IMPROVED SEIZURE CONTROL WITH VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention