BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2180949 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01636
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S PHYSICIAN THAT THE PT HAD VOCAL CORD PARALYSIS AFTER BEING IMPLANTED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other