BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1289413 · Received January 13, 2009

    Report

    Report Number
    1644487-2009-00075
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    February 1, 2003
    Report Date
    December 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LARYNGOPHARYNGEAL DYSFUNCTION FROM THE IMPLANT VAGAL NERVE STIMULATOR. ZALVAN, C. ET. AL. THE LARYNGOSCOPE 113. FEBRUARY 2003: PP. 221-225.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT PRESENTED VOICE ALTERATION IMMEDIATELY AFTER DEVICE IMPLANTATION SURGERY. UPON MEDICAL EXAMINATION, IT WAS FOUND THAT THE PATIENT'S LEFT VOCAL CORD WAS IMMOBILE. THE FOLLOW UP SEVEN MONTHS LATER REVEALED MINIMAL ACTIVITY OF THE LEFT VOCAL CORD WHICH WOULD POSSIBLY DEMONSTRATE EARLY RECOVERY OF THE VOCAL CORD PARESIS. THE REPORTER INDICATED THAT THE PATIENT'S DEVICE WAS PROGRAMMED ON AND THE VOCAL CORD PARESIS DID NOT APPEAR TO BE AFFECTED BY DEVICE STIMULATION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION SUCH AS PATIENT IMPLANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    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 10 YR Required Intervention