BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1810743 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00459
    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. IT WAS REPORTED THAT THE PT HAD "IMPROVED FUNCTIONING".

    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