BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3122995 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01483
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BHAT S, LYSENKO L, NEIMAN ES, RAO GK, CHOKROVERTY S. INCREASING OFF-TIME IMPROVES SLEEP-DISORDERED BREATHING INDUCED BY VAGAL NERVE STIMULATION. EPILEPTIC DISORD. 2012;14(4):432-7.HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/23247901.

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF THE PUBLISHED ABSTRACT ENTITLED ¿INCREASING OFF-TIME IMPROVES SLEEP-DISORDERED BREATHING INDUCED BY VAGAL NERVE STIMULATION¿; BHAT S, LYSENKO L, NEIMAN ES, RAO GK, CHOKROVERTY S. (EPILEPTIC DISORD. 2012;14(4):432-7), IT WAS IDENTIFIED THAT THERE WAS A VNS PATIENT WITH SLEEP APNEA. BY INCREASING THE OFF-TIME OF THE VNS FROM 3 MINUTES TO 5 MINUTES OF THE VNS THE VNS-INDUCED ARTERIAL OXYGEN DESATURATIONS IN SLEEP RESOLVED THE HYPOPNEA EVENTS. THE INCREASED OFF TIME OF THE VNS IMPROVE APNOEA-HYPOPNOEA INDEX FROM THE MODERATELY ELEVATED RANGE TO THE NORMAL RANGE. LOWERING THE VNS FREQUENCY FROM 30 HZ TO 20 HZ DECREASED THE NUMBER OF EVENTS WITH DESATURATION OF OXYGEN BUT THE MAJORITY OF THE EVENTS WERE STILL HYPOPNEA. THE COMBINATION OF LOWERING THE FREQUENCY AND INCREASING THE OFF TIME COMPLETELY ELIMINATED THE VNS ASSOCIATED OXYGEN DESATURATION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224556 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening| R