BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROCYBERNETIC PROSTHESIS

    MDR report key: 758211 · Received September 2, 2006

    Report

    Report Number
    MW1040280
    Event Type
    Injury
    Date Received
    September 2, 2006
    Date of Event
    July 2, 2006
    Report Date
    September 2, 2006
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DEVICE WAS PROGRAMMED TO STIMULATE THE NERVE FOR 30 SECONDS EVERY 3 MINUTES, WHEN IT MALFUNCTIONED IT WAS PUTTING ME INTO ASYTOLE DURING THE ON CYCLES. MY NEUROLOGIST TURNED OFF THE DEVICE IN THE ER AND I REGAINED A NORMAL HEART BEAT. I WAS KEPT IN THE HOSPITAL AN ADDITIONAL 3 DAYS FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROCYBERNETIC PROSTHESIS VAGUS NERVE STIMULATOR LYJ CYBERONICS 101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| S