BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1299021 · Received January 29, 2009

    Report

    Report Number
    1644487-2009-00133
    Event Type
    Injury
    Date Received
    January 29, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 2, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: J.J. ARDESCH, HCE. VAN LAMBALGEN, A.W. DE WEERD. "CENTRAL TYPE SLEEP APNEAS; AN ADVERSE EFFECT OF VAGUS NERVE STIMULATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A SCIENTIFIC ARTICLE THAT VAGUS NERVE STIMULATION CAUSES SLEEP APNEA. A PATIENT HAD DEVELOPED A CENTRAL TYPE OF APNEAS DURING THE USE OF VNS. THE PATIENT WAS ANALYZED FOR TWO NIGHTS WITH POLYSOMNOGRAPHY. THE TEST RESULTS SHOWED THAT THE PATIENTS WERE EXPERIENCING SLEEP APNEA WITH VNS SYSTEM.

    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