BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2396052 · Received January 3, 2012

    Report

    Report Number
    1644487-2012-00012
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    January 1, 1999
    Report Date
    December 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: EFFECT OF VAGAL NERVE STIMULATION ON SLEEP. EPILEPSIA, 1999, 40:137. VAUGHN, BV, D, CRUZ, OF, FREENWOOD, R, BERNARD, EJ. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING THE ARTICLE FOR REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF AN ARTICLE REFERENCED FROM A PREVIOUSLY REPORTED ARTICLE (MARZEC, MARY, JONATHAN EDWARDS, OREN SAGHER, GAIL FROMES, AND BETH A. MALOW. "EFFECTS OF VAGUS NERVE STIMULATION ON SLEEP-RELATED BREATHING IN EPILEPSY PATIENTS." EPILEPSIA 44 (2003): 930-35; REFERENCE MDR #1644487-2008-01873), IT WAS NOTED ANOTHER AUTHOR CONCLUDED THAT "AT RELATIVELY LOW STIMULUS INTENSITIES AND FREQUENCIES, VNS INCREASED REM SLEEP, A VULNERABLE STATE FOR SLEEP DISORDERED BREATHING." ATTEMPTS TO OBTAIN THE FULL ARTICLE FOR FURTHER REVIEW AND ATTEMPTS TO THE AUTHOR FOR FURTHER INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE ARTICLE REVEALED THAT TO EXAMINE THE EFFECT OF VAGAL NERVE STIMULATION ON SLEEP, AMBULATORY POLYSOMNOGRAPHY WAS PERFORMED ON TEN PATIENTS WITH INTRACTABLE EPILEPSY BEFORE VNS IMPLANT AND AFTER THREE MONTHS OF STIMULATION. FIVE PATIENTS HAD LOW INTENSITY, LOW FREQUENCY STIMULATION AND FIVE PATIENTS HAD HIGH INTENSITY, HIGH FREQUENCY STIMULATION. RESULTS: ALL OF THE SUBJECTS (5 PATIENTS) IN THE HIGH INTENSITY, HIGH FREQUENCY STIMULATION GROUP DEMONSTRATED A DECREASE IN TOTAL TIME IN REM SLEEP (RANGING FROM 13 TO 62 MINUTE DECREASE) AND REM SLEEP PERIODS WERE LESS FRAGMENTED. SUBJECTS IN THE LOW INTENSITY LOW FREQUENCY GROUP (5 PATIENTS) DEMONSTRATED EITHER NO CHANGE OR AN INCREASE IN TOTAL REM TIME AND NO CHANGE IN REM FRAGMENTATION. THERE WAS NO CHANGE IN REM LATENCY IN EITHER GROUP. CONCLUSIONS: THESE FINDINGS SUGGEST THAT HIGH INTENSITY, HIGH FREQUENCY VAGAL NERVE STIMULATION DECREASES TOTAL REM SLEEP AND WOULD SUPPORT THE HYPOTHESIS OF ACTIVATION OF THE REM INHIBITATORY MECHANISMS. MANUFACTURER REVIEW OF THE ARTICLE CONFIRMED THE REPORTED EVENTS WERE SLEEP DISTURBANCES ONLY, AND NOT SLEEP APNEA. ATTEMPTS FOR FURTHER INFORMATION FROM THE AUTHOR WERE UNSUCCESSFUL AS THE AUTHOR DECLINED TO RESPOND TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK PULSE GEN MODEL UNK LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention