BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2081463 · Received April 20, 2011

    Report

    Report Number
    1644487-2011-00852
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HE WAS HAVING INCREASED SEIZURES OVER THE PREVIOUS TWO WEEKS THAT WERE OVER HIS PRE-VNS BASELINE SEIZURE LEVELS. THE REPORTER STATED HIS TREATING NEUROLOGIST CONFIRMED PROPER FUNCTION OF THE REPORTER'S VNS. ATTEMPTS TO THE TREATING NEUROLOGIST FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011454

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR