BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODE 102

    MDR report key: 1243691 · Received November 25, 2008

    Report

    Report Number
    1644487-2008-02852
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    October 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: EBBEN, PH.D, MATHEW R., NITIN K. SETHI, M.D., MARY CONTE, PH.D., CHARLES P. POLLAK, M.D, AND DOUGLAS LABAR, M.D. "VAGUS NERVE STIMULATION, SLEEP APNEA, AND CPAP TITRATION." JOURNAL OF CLINICAL SLEEP MEDICINE 4 (2008): 471-73.

    Description of Event or Problem · 1

    THE REPORTER INDICATED IN A SCIENTIFIC ARTICLE THAT A VNS PATIENT'S PREEXISTING SLEEP APNEA WAS EXACERBATED BY VNS STIMULATION AND REQUIRED CPAP TITRATION. THE REPORTER STATED THAT THE PATIENT'S THERAPY SETTINGS WERE NOT ALTERED DUE TO THE PATIENT'S EFFICACY AT THE CURRENT SETTINGS. DURING THE STUDY, IT WAS REVEALED "THAT ADEQUATE CPAP TITRATION COULD NOT BE ACHIEVED IN THE PRESENCE OF THE PATIENT'S STANDARD VNS ON/OFF CYCLING MODE. HOWEVER, WHEN THE PATIENT WAS RESTUDIED WITH HIS VNS DEVICE TURNED OFF, A NASAL CPAP PRESSURE OF 13 CM H2O RESULTED IN EFFECTIVE TREATMENT OF HIS SEVERE OSAHS." "AFTER APPROXIMATELY 2 MONTHS OF NIGHTLY CPAP USE, THE PATIENT REPORTED FEELING MORE ALERT DURING THE DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODE 102 LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention