BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1080723 · Received July 18, 2008

    Report

    Report Number
    1644487-2008-01654
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    January 1, 2002
    Report Date
    June 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARDESCH JJ, ET AL., "CARDIAC RESPONSED OF VAGUS NERVE STIMULATION: INTRAOPERATIVE BRADYCARDIA AND SUBSEQUENT CHRONIC STIMULATION", CLIN NEUROL NEUROSURG (2007), DOI: 10.1016/J.CLINEURO.2007.07.024.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE REVIEWED BY MANUFACTURER THAT THE VNS PT EXPERIENCED A BRADYCARDIA EVENT INTRA-OPERATIVELY, UPON INITIAL IMPLANTATION OF THE VNS DEVICE, DURING LEAD TEST. THE FOLLOWING IS THE SUMMARY OF THIS PTS EVENT ACCORDING TO THE INFO IN THE REFERENCED ARTICLE. NO CARDIAC HISTORY UPON PHYSICAL EXAMINATION. HEART RATE PRIOR TO STIMULATION WAS 63 BEATS/MINUTE. ON INTRAOPERATIVE TESTING (LEAD TEST) A BRADYCARDIA EVENT OCCURRED AT 54 BEATS/MINUTE. THE SECOND TEST SHOWED THE SAME EFFECT ON THE HEART RATE. AFTER THE LEAD TEST WAS COMPLETED, THE HEART RATE RETURNED TO NORMAL. THE VNS DEVICE WAS IMPLANTED AS PLANNED. NO FURTHER CARDIAC EVENTS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening