BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN

    MDR report key: 1810823 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00430
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    April 26, 2007
    Report Date
    June 5, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ARDESCH JJ, ET AL., VAGUS NERVE STIMULATION FOR MEDICALLY REFRACTORY EPIEPSY: A LONG-TERM FOLLOW-UP STUDY, SEIZURE: EUR J EPIL (2007), DOI: 10/1016/J.SEIZURE.2007.04.005.

    Description of Event or Problem · 1

    REVIEW OF AN ARTICLE REVEALED THAT A VNS PT UNDERWENT EXPLANTATION OF THE VNS THERAPY SYSTEM DUE TO LACK OF EFFICACY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1