BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1241164 · Received November 20, 2008

    Report

    Report Number
    1644487-2008-02704
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    May 29, 2001
    Report Date
    October 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: HISTOLOGICAL APPEARANCE OF CHRONICALLY STIMULATED VAGUS NERVE IN A PEDIATRIC PATIENT. PEDIATR NEUROSURG 2001, 35:99-102 2001 R SHANE TUBBS. ET AL.

    Description of Event or Problem · 1

    AN ARTICLE ABOUT THE HISTOLOGICAL APPEARANCE OF A CHRONICALLY STIMULATED VAGUS NERVE IN A PEDIATRIC REPORTER INDICATED VNS THERAPY MODERATED A PATIENT'S ATONIC EPISODES, BUT THE PATIENT EXPERIENCED "OCCASIONAL HOSPITALIZATIONS FOR STATUS EPILEPTICUS." THE PATIENT PASSED AWAY DUE TO ASPHYXIATION (REPORTED ON MEDWATCH 1644487-2008-02703). THE VNS THERAPY SYSTEM WAS EXPLANTED WITH "1.5 CM OF UNSTIMULATED NERVE SUPERIORLY AND INFERIORLY." THE ELECTRODES WERE DISSECTED FROM THE NERVE "REVEALING GROSSLY NORMAL NERVE ABOVE AND BELOW THE STIMULATOR." "ABUNDANT INFLAMMATORY CELLS WERE PRESENT AROUND THE STIMULATED NERVE SECTION." "SEVERE MYELIN LOSS AND OCCASIONAL MYELIN DIGESTION CHAMBERS WERE SEEN IN THE NERVE FIBERS. WITH MODIFIED TRICHROME AND LUXO FAST BLUE STAINS, THIS LOSS WAS ESTIMATED TO BE NEARLY 90%." GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    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 Other| R