BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2092596 · Received May 9, 2011

    Report

    Report Number
    1644487-2011-01007
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    August 26, 2010
    Report Date
    April 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAS BEEN EXPERIENCING CONSTANT VOICE HOARSENESS SINCE SURGERY. THE HOARSENESS IS NOT ASSOCIATED WITH STIMULATION AND DIAGNOSTICS ARE WITHIN NORMAL RANGE. THE PT PHYSICIAN CONSULTED AN ENT COLLEAGUE AND HE FELTS IT MAY BE A VOCAL CORD PARALYSIS. THERE IS NO INTERVENTION THAT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 2736

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability