BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 5124699 · Received October 2, 2015

    Report

    Report Number
    1644487-2015-05999
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    July 31, 2014
    Report Date
    September 9, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S LEFT VOCAL CORDS WERE AFFECTED. NO INTERVENTIONS WERE REPORTED TO HAVE BEEN TAKEN AND VOCAL CORD ISSUE WAS REPORTED TO HAVE RESOLVED SPONTANEOUSLY. THE ENT PHYSICIAN BELIEVED THAT THE ISSUE WAS CAUSED BY THE VNS SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING VOICE ALTERATION FOLLOWING A RECENT VNS IMPLANT SURGERY. PATIENT'S VNS WAS NOT TURNED ON DURING SURGERY ON (B)(6) 2014 AND THE VOICE ALTERATION WAS REPORTED TO BE NOT RELATED TO STIMULATION. INFORMATION WAS LATER RECEIVED THAT THE PATIENT'S VOICE ALTERATION HAD STILL NOT RESOLVED AFTER TWO MONTHS FROM VNS IMPLANT. IT IS REPORTED THAT THE VOICE HAD IMPROVED BUT TOWARDS THE END OF THE WORK WEEK, PATIENT'S VOICE SOUNDS LIKE A WHISPER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DIAGNOSED WITH VOCAL COD PARALYSIS IN (B)(6) 2015. PATIENT IS PARTIALLY RECOVERED BUT STILL HAS EPISODES OF NO VOICE FORM TIME TO TIME. PATIENT BELIEVES IT TO BE RELATED TO THE SURGERY FROM WHICH SHE NEVER RECOVERED FULLY. PATIENT'S VOICE ALTERATION WAS BETTER BUT HAS RETURNED RECENTLY. VOICE ALTERATION OCCURS WITH STIMULATION USUALLY BUT ALSO OTHERWISE. PATIENT PLAYS A SAXOPHONE IN A BAND AND SHE LOSES HER VOICE FOR 24HR AFTERWARDS. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655174 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202844

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other