BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR MODEL UNKNOWN

    MDR report key: 1953498 · Received January 5, 2011

    Report

    Report Number
    1644487-2011-02971
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABSTRACT: VAGUS NERVE STIMULATION (VNS) IN CHILDREN WITH REFRACTORY SECONDARY GENERALIZED OR MULTIFOCAL EPILEPSY WHO WERE NOT CANDIDATES FOR CORTICAL RESECTION. AUTHORS: MEIRE ARGENTONI-BALDOCHI, C. FORSTER, C. BAISE, C. CUKIERT, V. MELLO, A. CUKIERT, J. BURATTINI, AND P. MARIANI. JOURNAL: EPILEPSIA 0 SUPPL. 0 (ABST. 2.272), 2010.

    Description of Event or Problem · 1

    AN ABSTRACT WAS REC'D CALLED: VAGUS NERVE STIMULATION (VNS) IN CHILDREN WITH REFRACTORY SECONDARY GENERALIZED OR MULTIFOCAL EPILEPSY WHO WERE NOT CANDIDATES FOR CORTICAL RESECTION. IN THE ABSTRACT A PT HAVING INCREASED SEIZURES AFTER VNS STIMULATION OUTPUT CURRENT WAS SET HIGHER THAN 2.5MA OUTPUT CURRENT WAS REPORTED. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR MODEL UNKNOWN LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1