BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1120810 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01912
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "SLEEP-RELATED BREATHING DISORDERS IN CHILDREN WITH VAGAL NERVE STIMULATORS" PEDIATRIC NEUROLOGY VOL. 39 NO.2 2008.

    Description of Event or Problem · 1

    FINDINGS OF OBSTRUCTIVE SLEEP APNEA IN CHILDREN WITH VAGAL NERVE STIMULATORS AND WHO MANIFESTED SEVERE EPILEPSY WERE REPORTED IN AN ARTICLE.

    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