BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1040549 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01115
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2006
    Report Date
    April 11, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT WAS EXPERIENCING PAIN WITH THE VNS DEVICE. FURTHER FOLLOW UP WITH THE PHYSICIAN REVEALED THAT THE PT EXPERIENCED THROAT PAIN AND VOICE ALTERATION FOLLOWING IMPLANTATION OF THE DEVICE. THE PHYSICIAN OPTED TO INITIATE STIMULATION BY SLOWLY RAMPING UP THE SETTING TO ATTEMPT TO ACHIEVE EFFICACY. ONCE AT A CERTAIN SETTING, THE PT WAS EXPERIENCING PAINFUL STIMULATION IN THE THROAT AND VOICE ALTERATION WITH STIMULATION. THE PHYSICIAN ATTEMPTED TO INCREASE THE SETTING FURTHER, HOWEVER, THE PAIN WAS NOT TOLERABLE FOR THE PT. THE PT WAS REFERRED TO AN ENT SURGEON AND WAS SUBSEQUENTLY DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS. THE PT IS BEING MONITORED BY THE SURGEON AND THE DEVICE REMAINS ON AT THIS TIME, WITH NO PLANS TO INCREASE THE SETTINGS FOR THE MOMENT. THE PHYSICIAN REPORTED THAT DIAGNOSTIC TESTING IS ROUTINELY PERFORMED AND THE DEVICE IS FUNCTIONING WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1598

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability