BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2010599 · Received March 1, 2011

    Report

    Report Number
    1644487-2011-00369
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    November 5, 2010
    Report Date
    February 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 02/23/2011, A CYBERONICS CONSULTANT REPORTED THAT A VNS PT WAS EXPERIENCING LEFT LARYNGEAL NERVE PARALYSIS AS A RESULT OF THE IMPLANT SURGERY. THE PT WAS NOTED TO BE IMPROVING AS THE VNS DEVICE WAS NOT PROGRAMMED ON. IT WAS DETERMINED BY AN EAR NOSE AND THROAT PHYSICIAN THAT THE PARALYSIS WAS PRESENT. AS A RESULT OF THE PARALYSIS, THE PT IS HAVING LARYNGEAL SPASMS, WHICH IS CAUSING ANXIETY AND PANIC ATTACKS WITH STRIDOR. DUE TO THESE PROBLEMS, THE PHYSICIAN DETERMINED THAT THE PT NEEDED A TRACHEOSTOMY, WHICH OCCURRED IN THE LAST TWO WEEKS. THE PT WAS EXPERIENCING BREATHING ISSUES AS A RESULT OF THE PANIC ATTACKS. CURRENTLY, THE PT HAS NOT BEEN PROGRAMMED ON AND IS BEING REFERRED TO A HOSP FOR EVAL. AFTER EVALUATION, IT WILL BE DECIDED IF THE DEVICE WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 2595

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention