BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1222388 · Received November 5, 2008

    Report

    Report Number
    1644487-2008-02662
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ADMITTED TO THE HOSP FOR PNEUMONIA. FOLLOW UP WITH AN ENT PHYSICIAN REVEALED THAT SWOLLEN ARYTENOIDS WERE CLOSING CAUSING OBSTRUCTION, AND VOCAL CORD PARALYSIS. THE PATIENT'S DEVICE WAS TURNED OFF AND AFTER ONE WEEK, THE SWELLING WAS GONE. THE PT IS CURRENTLY ON MEDICATION AND DOING WELL. THERE ARE NO PLANS TO REMOVE HER DEVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO SURROUNDING THE PT'S EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010093

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization