BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1810719 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00446
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    October 13, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROMES, GAIL. "EFFICACY OF VAGUS NERVE STIMULATION IN ADULTS DURING 5 YEARS OF TREATMENT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PT DID NOT RECEIVE EFFICACY AFTER 5 YEARS OF VNS THERAPY. ATTEMPTS TO OBTAIN ADD'L INFO ARE UNDERWAY.

    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