BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 669087 · Received January 27, 2006

    Report

    Report Number
    1644487-2006-00051
    Event Type
    Injury
    Date Received
    January 27, 2006
    Date of Event
    December 14, 2005
    Report Date
    December 29, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT CONTINUED TO EXPERIENCE HOARSENESS AND HAD TO STRAIN TO SPEAK IN THE EVENINGS, APPROXIMATELY 15 DAYS POST IMPLANT. STIMULATION HAD NOT YET BEEN INITIATED. TREATING PHYSICIAN INDICATED THAT AT FOLLOW-UP OFFICE VIST 23 DAYS POST IMPLANT, THE PATIENT'S VOICE HAD IMPROVED, BUT WAS STILL HOARSE. THE PATIENT WAS REFERRED TO ENT FOR EVALUATION. STIMULATION WAS NOT INITIATED AT THIS OFFICE VISIT. REPORT IS INCOMPLETE, BECAUSE DEVICE TRACKING INFORMATION WAS NOT FORWARDED TO MANUFACTURER AT THE TIME OF IMPLANT. ATTEMPTS TO OBTAIN IT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD (MUZ) MUZ CYBERONICS, INC. 302-20 9946

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability