BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1471022 · Received September 11, 2009

    Report

    Report Number
    1644487-2009-01961
    Event Type
    Injury
    Date Received
    September 11, 2009
    Date of Event
    October 1, 2001
    Report Date
    August 14, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: ZAAIMI B, GREBE R, BERQUIN P, PATRICK B. "VAGUS NERVE STIMULATION THERAPY INDUCES CHANGES IN HEART RATE OF CHILDREN DURING SLEEP". EPILEPSIA 48: 923-930. 2007.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT STUDY PATIENT SHOWED CHANGE IN HEART RATE WHILE RECEIVING VAGUS NERVE STIMULATION. IT WAS INDICATED THAT THE CHANGE IN HEART RATE WAS RELATED TO VNS THERAPY. THERE WAS A INCREASE IN HEART RATE NOTED FOR THIS PARTICULAR CHILD PATIENT. THIS PATIENT WAS ALSO INCLUDED IN AN ARTICLE BY THE SAME AUTHOR TITLED "VAGUS NERVE STIMULATION INDUCES CONCOMITANT RESPIRATORY ALTERATIONS AND A DECREASE IN SAO2 IN CHILDREN" WHICH WAS REPORTED IN MANUFACTURER REPORT # 1644487-2006-00105. THIS PATIENT WAS ALSO INCLUDED IN AN ARTICLE BY THE SAME AUTHOR TITLED "VAGUS NERVE STIMULATION INDUCES CHANGES IN RESPIRATORY SINUS ARRHYTHMIA OF EPILEPTIC CHILDREN DURING SLEEP", WHICH WAS REPORTED IN MANUFACTURER REPORT # 1644487-2009-01973.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention