BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYJ

    MDR report key: 819800 · Received February 9, 2007

    Report

    Report Number
    1644487-2007-00018
    Event Type
    Injury
    Date Received
    February 9, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 11, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    p970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VNS THERAPY SYSTEM LABELING LISTS HEART RATE/RHYTHM CHANGES AS A POTENTIAL ADVERSE EVENT POSSIBLY ASSOCIATED WITH SURGERY OR STIMULATION.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT EXPERIENCED BRADYCARDIA DURING AN INITIAL VNS IMPLANT SURGERY. THE PT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE EVENT. AFTER IMPLANTING THE LEAD, A SYSTEM DIAGNOSTIC TEST WAS RUN AND PROFOUND BRADYCARDIA DEVELOPED FOR 10 SECONDS. ATROPINE WAS ADMINISTERED AND THE BRADYCARDIA RESOLVED WITH NO DROP IN BLOOD PRESSURE. ANOTHER SYSTEM DIAGNOSTIC TEST WAS PERFORMED AT INCISION CLOSURE RESULTING IN OK RESULTS. THE SURGEON NOTED THAT ATROPINE WAS PRESENT IN THE PT'S SYSTEM AT THE TIME OF THE SECOND DIAGNOSTIC TEST. FOLLOW UP WITH THE PT'S TREATING, PHYSICIAN INDICATED HE IS AWARE OF THE BRADYCARDIA EVENT, AND HAS NOT YET ACTIVATED THE PT'S VNS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYJ PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 13118

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R