BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1080731 · Received July 18, 2008

    Report

    Report Number
    1644487-2008-01653
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    September 1, 1999
    Report Date
    June 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARDESCH JJ, ET AL., "CARDIAC RESPONSES OF VAGUS NERVE STIMULATION: INTRAOPERATIVE BRADYCARDIA AND SUBSEQUENT CHRONIC STIMULATION", CLIN NEUROL NEUROSURG (2007), DOI: 10.1016/J.CLINEURO.2007.07.024.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE REVIEWED BY MFR THAT THE VNS PT EXPERIENCED LEFT VOCAL CORD PARALYSIS FOLLOWING THE DEVICE IMPLANTATION PROCEDURE. THE FOLLOWING IS A SUMMARY OF THIS PTS' EVENT ACCORDING TO THE INFO REFERENCED IN THE ARTICLE. STRONG VOICE ALTERATIONS WERE REPORTED WITHIN 3 DAYS FOLLOWING IMPLANTATION. LARYNGOSCOPY CONFIRMED A LEFT VOCAL CORD PARALYSIS. AT THE PTS REQUEST, THE INITIATION OF THE VNS WAS POSTPONED UNTIL THE VOICE IMPROVED. THREE MONTHS AFTER IMPLANTATION, THE VOICE REGAINED ITS STRENGTH AND THE HOARSENESS DIMINISHED. VNS WAS THEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S