BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1080734 · Received July 18, 2008

    Report

    Report Number
    1644487-2008-01648
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    June 1, 1999
    Report Date
    June 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARDESCH JJ, ET AL., "CARDIAC RESPONSES 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 MFR 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 PT'S EVENT ACCORDING TO THE INFO IN THE REFERENCED ARTICLE. THE PT HAD NO MEDICAL HISTORY OF CARDIAC DISEASE. PHYSICAL EXAMINATION AT FIRST CONSULATION PRIOR TO IMPLANTATION WAS NORMAL, BLOOD PRESSURE WAS 130/85 MM HG AND HEART RATE WAS 84 BEATS/MINUTE. IN 1999, A VNS SYSTEM WAS IMPLANTED. DURING THE INTRAOPERATIVE LEAD TEST OF VNS THE PT'S HEART RATE CHANGED FROM 65 BEATS/MINUTE TO A BRADYCARDIA OF APPROX 43 BEATS/MINUTE DURING THE PERIOD OF STIMULATION. A SECOND TEST RESULTED IN A SIMILAR RESPONSE WITH 25 BEATS/MINUTE. HEART RATE RETURNED TO NORMAL, RAPIDLY AFTER STIMULATION AND THE IMPLANTATION PROCEDURE WAS CARRIED OUT AS PLANNED. POSTOPERATIVELY, THERE WERE NO COMPLICATIONS. AFTER 10 DAYS VNS WAS INITIATED UNDER ECG MONITORING. NO FURTHER CARDIAC EFFECTS 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 32 YR Life Threatening