BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1891004 · Received October 29, 2010

    Report

    Report Number
    1644487-2010-02428
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HAVING INCREASED SEIZURES. A VNS BATTERY ESTIMATE PERFORMED YIELDED APPROX 1.38 YEARS REMAINING. PER THE REPORTER, THE PT HAD BEEN UNDER A LOT OF RECENT STRESS WHICH MAY HAVE CONTRIBUTED TO THE SEIZURE INCREASE. ALL ATTEMPTS TO THE REPORTER 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 11003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR