BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1569664 · Received December 2, 2009

    Report

    Report Number
    1644487-2009-02680
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    January 1, 2001
    Report Date
    November 9, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: MAJOIE, H.J. MARIANNE, M. WILLEM BERFELO, ALBERT P. ALDENKAMP, SILVIA M. EVERS, ALFONS G. KESSELS, AND WILLY O. RENIER. "VAGUS NERVE STIMULATION IN CHILDREN WITH THERAPY-RESISTANT EPILEPSY DIAGNOSED AS LENNOX-GASTAUT SYNDROME." JOURNAL OF CLINICAL NEUROPHYSIOLOGY (2001): 419-28. PRINT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES DUE TO UNK REASONS. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CAUSE OF THE INCREASE IN SEIZURES HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1