BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1509539 · Received October 15, 2009

    Report

    Report Number
    1644487-2009-02307
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    May 26, 2009
    Report Date
    September 15, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY THE VNS PATIENT, THAT AN ENT HAD DIAGNOSED HER WITH VOCAL CORD PARALYSIS AFTER HAVING BEEN IMPLANTED WITH THE VNS DEVICE. THE DEVICE HAD NOT BEEN PROGRAMMED ON AT THE TIME THE PATIENT REPORTED THE EVENT. ADDITIONALLY, THE PATIENT'S VOICE WAS NOTICEABLY HOARSE WHEN SPEAKING TO THE MANUFACTURER REPRESENTATIVE. FURTHER FOLLOW UP WITH THE VNS PATIENT'S TREATING NEUROLOGIST REVEALED THAT THE PATIENT'S VOICE HAD RETURNED AND THERE WAS NO NOTICEABLE HOARSENESS. THE PATIENT DID NOT RECALL THE NAME OF THE ENT WHO EVALUATED AND DIAGNOSED THE VOCAL CORD PARALYSIS AND THE NEUROLOGIST WAS NOT AWARE OF THE ENT'S NAME OR CONTACT INFORMATION EITHER. THEREFORE FURTHER FOLLOW UP WITH THE ENT HAS NOT BEEN POSSIBLE TO DATE. THE NEUROLOGIST PROGRAMMED THE DEVICE ON AT LOW SETTINGS AT THE FOLLOW UP VISIT AND THE PATIENT TOLERATED THE SETTINGS WELL. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT 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 200950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability