BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1822471 · Received August 26, 2010

    Report

    Report Number
    1644487-2010-01946
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 27, 2010
    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 INITIALLY REPORTED THAT A PT HAS EXPERIENCED HOARSENESS SINCE IMPLANT WHICH HAS NOT SIGNIFICANTLY IMPROVED. THE PHYSICIAN INDICATED THAT HE SUSPECTS THE RECURRENT LARYNGEAL NERVE FIBERS WERE WITHIN PORTIONS OF THE NERVE WRAPPED BY THE LEAD AND THAT THE PT HAS LEFT VOCAL CORD PARALYSIS AS A RESULT. THE PT WILL BE SEEN BY ANOTHER PHYSICIAN FOR FURTHER EVAL. THE PHYSICIAN STATED THAT HE SEES NO POINT TO NOT PROGRAM THE PT'S DEVICE ON AT THIS POINT AND WILL BE DOING SO IN THE IMMEDIATE FUTURE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 2311

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention