BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1246325 · Received November 26, 2008

    Report

    Report Number
    1644487-2008-02871
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    October 1, 2003
    Report Date
    October 28, 2008
    Manufacturer
    CYBERONICS, INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: HOLMES MD, CHANG M, KAPUR V. SLEEP APNEA AND EXCESSIVE DAYTIME SOMNOLENCE INDUCED BY VAGAL NERVE STIMULATION. NEUROLOGY 2003:61:1126-9.

    Description of Event or Problem · 1

    THE REPORTER INDICATED IN A SCIENTIFIC ARTICLE THAT A VNS PATIENT DEVELOPED EXCESSIVE DAYTIME SLEEPINESS AFTER VNS PLACEMENT. THE REPORTER ATTRIBUTED THIS EVENT TO THE APNEAS, HYPOPNEAS, TACHYPNEAS AND AROUSALS ASSOCIATED WITH VNS STIMULATION DURING SLEEP. THE REPORTER STATED THAT THE EPISODES OCCURRED EXCLUSIVELY DURING THE 30-SECOND STIMULATION AND THAT THE PATIENT REFUSED TO HAVE HER DEVICE DISABLED DURING SLEEP. AT THE PATIENT'S REQUEST, VNS THERAPY WAS DISCONTINUED AFTER POLYSOMNOGRAPHY, RESULTING IN A COMPLETE RESOLUTION OF DAYTIME SLEEPINESS.

    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 21 YR Life Threatening