BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 531646 · Received June 25, 2004

    Report

    Report Number
    1644487-2004-00494
    Event Type
    Injury
    Date Received
    June 25, 2004
    Date of Event
    April 15, 2004
    Report Date
    May 27, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT HAS BEEN DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS. IT WAS REPORTED THAT THE PT EXPERIENCED PROBLEMS WITH CONTINUOUS HOARSENESS AFTER IMPLANT AND THAT AN ENT HAD PERFORMED A SCOPE PROCEDURE, DIAGNOSING LEFT VOCAL CORD PARALYSIS. STIMULATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI BIPOLAR LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability PULSE GENERATOR.