BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2230488 · Received August 12, 2011

    Report

    Report Number
    1644487-2011-01866
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIMMONS, JERALD H., AND SHAARON BARLOW. "VAGUS NERVE STIMULATION THERAPY ENHANCES OBSTRUCTIVE RESPIRATIONS DURING SLEEP." 2011 SLEEP 2011. (B)(6). LECTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A POSTER PRESENTATION TITLED "VAGUS NERVE STIMULATION THERAPY ENHANCES OBSTRUCTIVE RESPIRATIONS DURING SLEEP" FROM (B)(6) MEETING, THAT SIX PTS WERE DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA (OSA) THAT IS ASSOCIATED WITH VNS STIMULATION. THE PTS WERE PART OF A THREE PART STUDY ON THE ASSOCIATION OF VNS STIMULATION AND OSA. THE FIRST PART OF THE STUDY MODIFIED VNS SETTINGS TO CONFIRM A RELATIONSHIP OF THE VNS STIMULATION TO THE OSA. IN PART TWO OF THE STUDY, THE VNS WAS DISABLED AND THE CPAP OR BIPAP WAS TITRATED TO SETTINGS THAT PROPERLY PREVENTED THE OBSTRUCTIVE RESPIRATIONS. IN PART THREE OF THE STUDY, THE VNS WAS TURNED BACK ON WHILE MAINTAINING THE PAP LEVELS FROM STEP 2 AND THE OBSTRUCTIVE RESPIRATIONS RESUMED. THE VNS SETTINGS WERE ADJUSTED UNTIL PARAMETERS WERE IDENTIFIED THAT DID NOT INDUCE THE OBSTRUCTIVE RESPIRATIONS. ONLY THREE PTS WERE ABLE TO HAVE THEIR APNEA CONTROLLED BY STEP 2 OF THE STUDY WHEN VNS STIMULATION WAS DISABLED. THESE THREE PTS, THE REDUCTION OF THE SIGNAL FREQUENCY TO THE RANGE OF 10-15HZ MINIMIZED THE PROMOTION OF THE OBSTRUCTIVE RESPIRATIONS. THIS REPORT IS FOR THE FIRST PT IN THE STUDY THAT DID NOT PARTICIPATE IN STEP 3 OF THE STUDY. ATTEMPTS FOR FURTHER INFORMATION INCLUDING PT AND PRODUCT INFORMATION AS WELL AS FUTURE INTERVENTIONS 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 Life Threatening