BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL

    MDR report key: 1143662 · Received August 28, 2008

    Report

    Report Number
    1644487-2008-02052
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    January 1, 1998
    Report Date
    July 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE ARTICLE: LUNDGREN J, EKBERG O, OLSSON R. ASPIRATION: A POTENTIAL COMPLICATION TO VAGUS NERVE STIMULATION. EPILEPSIA 1998;39 (SEPTEMBER):998-1000.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A ARTICLE THAT TWO CHILDREN SHOWED AN INCREASED DEGREE OF ASPIRATION DURING CONTINUOUS VNS STIMULATION EVALUATED BY VIDEORADIOGRAPHY DURING BARIUM SWALLOW. BOTH CHILDREN WITH THE INCREASED DEGREE OF ASPIRATION HAS SEVERE MENTAL RETARDATION AND MOTOR RETARDATION AND WERE DEPENDENT ON ASSISTED FEEDING. ON THREE OCCASIONS ON HIS THIRD BIRTHDAY ONE OF THE CHILDREN WITH SWALLOWING DIFFICULTIES HAD DEVELOPED PNEUMONIAS, POSSIBLY ASPIRATION PNEUMONIAS. BOTH CHILDREN SHOWING THE INCREASED ASPIRATION HAVE A SEVERE MENTAL AND MOTOR IMPAIRMENT. SECOND CHILD FROM ARTICLE REFERENCED IN MDR NUMBER: 1644487-2008-02053.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other