BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1288587 · Received January 14, 2009

    Report

    Report Number
    1644487-2009-00010
    Event Type
    Injury
    Date Received
    January 14, 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. LARYNGOSCOPE 113. PP 221 - 225. FEBRUARY 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE FOLLOWING PTS HOW WERE IMPLANTED WITH THE VNS DEVICE THAT A PT DEVELOPED LEFT VOCAL CORD PARESIS FOLLOWING IMPLANT AS WELL AS DIFFICULTY BREATHING WHILE DRINKING. FOLLOW UP ONE MONTH LATER SHOWED NO IMPROVEMENT IN VOCAL CORD MOBILITY AND ANTIBIOTICS ADMINISTERED TO THE PT RESOLVED THE PT'S BREATHING DIFFICULTIES. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO INCLUDING PT IMPLANT INFO HAVE BEEN UNSUCCESSFUL AS THE AUTHOR NO LONGER HAS ACCESS TO THE PT'S CHART.

    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 3 YR Hospitalization| R