BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 1222385 · Received November 5, 2008

    Report

    Report Number
    1644487-2008-02661
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING CONTINUOUS VOICE ALTERATION AFTER IMPLANT SURGERY. THE PT WAS SEEN BY AN EAR/NOSE/THROAT PHYSICIAN WHO DIAGNOSED THE PT WITH "LEFT TRUE VOCAL CORD PARESIS," WHICH WAS BELIEVED TO HAVE BEEN A SIDE EFFECT OF IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 303 LYJ CYBERONICS, INC. 303-20 1686

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability