BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1165109 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02229
    Event Type
    Injury
    Date Received
    September 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANNEGERS JF, COAN SP, HAUSER WA, LEESTMA J. DUFFEL W, TARVER B. EPILEPSY, VAGAL NERVE STIMULATION BY THE NCP SYSTEM, MORTALLY AND SUDDEN, UNEXPECTED, UNEXPLAINED DEATH. EPILEPSIA 1998;39:206-12. ANNEGERS JF, COAN SP, HAUSER WA, LEESTMA J. EPILESPY, VAGAL NERVE STIMULATION BY THE NCP SYSTEM, ALL-CAUSE MORTALITY, AND SUDDEN UNEXPECTED, UNEXPLAINED DEATH. EPILEPSIA 200;41:549-53.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE REVIEWED BY MFR THAT VNS PTS EXPERIENCED ARRHYTHMIA.

    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 Life Threatening