BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2583979 · Received May 22, 2012

    Report

    Report Number
    1644487-2012-01282
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    May 1, 2012
    Report Date
    April 30, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ARON, MARGARET, HELEN VLACHOS-MAYER, AND DOMINIQUE DORION. "VOCAL CORD ADDUCTION CAUSING OBSTRUCTIVE SLEEP APNEA FROM VAGAL NERVE STIMULATION: CASE REPORT." THE JOURNAL OF PEDIATRICS (2012): 868-70. PRINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A SCIENTIFIC ARTICLE THAT A VNS PATIENT NOCTURNAL EPISODES OF APNEA AS WELL AS FREQUENT DIURNAL EPISODES OF TRANSIENT DYSPHONIA ASSOCIATED WITH APPARENT "CHOKING" EPISODES. THE PATIENT'S INITIAL VNS PARAMETERS WERE 500-MS AT 20 HERTZ EVERY 5 MINUTES AT AN INTENSITY OF 2.25 MA. A TOTAL OF 178 DESATURATIONS WERE RECORDED, REPRESENTING AN AVERAGE OF 12.4 DESATURATIONS PER HOUR. DETAILED EVALUATION REVEALED REGULAR DESATURATIONS EVERY 5 MINUTES, CORRESPONDING TO THE FREQUENCY OF VNS. AN OTOLARYNGOLOGIST INVESTIGATED THE PATIENT'S REPORTED CHOKING EPISODES AND EPISODIC DYSPHONIA. ON VISUALIZATION WITH A FLEXIBLE LARYNGOSCOPE, THE PATIENT'S VOCAL CORDS WERE SEEN TO ADDUCT WITH EACH STIMULATION BY THE VNS DEVICE. THE SETTINGS WERE ADJUSTED TO MAINTAIN SATISFACTORY SEIZURE CONTROL WHILE DIMINISHING THE APNEIC EPISODES. AN APPROPRIATE EQUILIBRIUM WAS REACHED BY CHANGING THE VNS STIMULATION FREQUENCY TO 30 HZ. AT THIS SETTING, THE PATIENT'S SEIZURES WERE ADEQUATELY CONTROLLED, ALL APNEIC EPISODES WERE ELIMINATED, AND CHOKING EPISODES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention