BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1080733 · Received July 18, 2008

    Report

    Report Number
    1644487-2008-01649
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    January 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
    NL
    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 MANUFACTURER THAT THE VNS PT EXPERIENCED A TACHYCARDIA EVENT AFTER IMPLANTATION OF THE VNS DEVICE, WHILE THE PT WAS RECEIVING NORMAL STIMULATION. THE FOLLOWING IS THE SUMMARY OF THIS PT'S EVENT ACCORDING TO THE INFO IN THE REFERENCED ARTICLE. THE PT HAS NO MEDICAL HISTORY OF ANY CARDIAC DISEASE. AFTER IMPLANTATION AND WHILE STIMULATION WAS PRESENT, THE PT REPORTED THAT SHE EXPERIENCED "A REBOUNCE TACHYCARDIA EVENT IN WHICH THE MAGNET WAS USED TO DISABLE STIMULATION FOR 10 MINUTES. THE TACHYCARDIA EVENT WAS NOT ABLE TO BE REPRODUCED UNDER ECG MONITORING AT THE HOSPITAL."

    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| R