BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1810709 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00389
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    October 1, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAJOR, PHILIPPE AND THIELE, EA. "VAGAL NERVE STIMULATION (VNS) FOR REFRACTORY EPILEPSY IN TUBEROUS SCLEROSIS COMPLEX."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO IMPROVEMENT IN THE PT'S SEIZURE FREQUENCY WITH VNS THERAPY.

    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