BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3112767 · Received May 14, 2013

    Report

    Report Number
    1644487-2013-01368
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    January 1, 2010
    Report Date
    April 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "VAGUS NERVE STIMULATION HAS A POSITIVE EFFECT ON MOOD IN PATIENTS WITH REFRACTORY EPILEPSY" BY S. KLINKENBERG, ET AL. (2012 MAY;114(4):336-40. DOI: 10.1016/J.CLINEURO.2011.11.016. EPUB 2011 NOV 30).

    Description of Event or Problem · 1

    FOLLOW UP WITH THE ARTICLE AUTHOR REVEALED ¿AS MENTIONED IN THE ARTICLE DESPITE OF REDUCTION OF SEIZURE FREQUENCY (OR IN SOME PATIENTS EVEN INCREASE OF SEIZURE FREQUENCY), MAJORITY OF PARENTS WERE VERY SATISFIED BY THE EFFECT DUE TO VNS. THERE WERE NO CHANGES OF AED DURING THE STUDY. NOR WERE THERE TECHNICAL PROBLEMS WITH THE DEVICE OR SERIOUS COMPLICATIONS/ADVERSE EVENTS DUE TO SURGERY.¿ NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A MANUFACTURER REVIEW OF THE ARTICLE ENTITLED "VAGUS NERVE STIMULATION HAS A POSITIVE EFFECT ON MOOD IN PATIENTS WITH REFRACTORY EPILEPSY" BY S. KLINKENBERG, ET AL. (2012 MAY;114(4):336-40. DOI: 10.1016/J.CLINEURO.2011.11.016. EPUB 2011 NOV 30) FOUND THAT A PATIENT WITH VNS THERAPY EXPERIENCED AN INCREASE IN SEIZURE FREQUENCY. ATTEMPTS FOR ADDITIONAL INFORMATION ARE STILL IN CONTINUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213229 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1