BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3143438 · Received June 3, 2013

    Report

    Report Number
    1644487-2013-01657
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    August 20, 2012
    Report Date
    May 7, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VOCAL CORD PARALYSIS AS DETERMINED BY AN EAR NOSE AND THROAT DOCTOR. THE VOCAL CORD PARALYSIS BEGAN SHORTLY AFTER IMPLANT SURGERY. IT WAS STATED THAT THE PATIENT'S DEVICE WAS TURNED ON, AND THAT AS OF (B)(6) 2013, THE PATIENT'S VOICE ISSUES HAVE IMPROVED SINCE INITIALLY NOTED AFTER THE REPLACEMENT. FOLLOW UP WITH THE NEUROLOGIST'S OFFICE FOUND THAT THE VOCAL CORD PARALYSIS WAS OBSERVED IN (B)(6) 2012. HOARSENESS AND PAIN IN THE VOCAL CORD AREA WERE ALSO OBSERVED AROUND THIS TIME AFTER IMPLANT SURGERY. PER THE NEUROLOGIST'S OFFICE, THE ENT CHECKED THE PATIENT AND FOUND THAT THE LEFT VOCAL CORD WAS IMMOBILE. AS OF THE LAST VISIT, THE PATIENT HAD A SCOPE DONE AND THE LEFT VOCAL CORD WAS STILL IMMOBILIZED. IN REGARDS TO INTERVENTION, IT WAS ONLY KNOWN THAT THE PATIENT WAS TAKING SPEECH THERAPY. THE HOARSENESS AND VOCAL CORD PARALYSIS IS CONSTANT AND NOT WITH STIMULATION. IT IS UNKNOWN IF THE PAIN WAS WITH STIMULATION. THE PATIENT HAS BEEN PROGRAMMED ON SINCE SURGERY TO PREVIOUS SETTINGS. THE FOLLOWING PARAMETERS WERE PROVIDED - OUTPUT CURRENT = 0.5MA, PULSEWIDTH = 30 MICROSECONDS, MAGNET OUTPUT CURRENT = 1MA. IT WAS UNKNOWN IF THE PATIENT HAS A MEDICAL HISTORY OF VOCAL CORD PARALYSIS; HOWEVER, IT WAS STATED THAT THE PARALYSIS OCCURRED SHORTLY AFTER SURGERY. IN PARTICULAR, IT WAS STATED STATED THAT THE VOCAL CORD PARALYSIS OCCURRED DUE TO THE PATIENT BEING BURNT WITH THE LEADS. IT WAS STATED THAT THE BURN OCCURRED WHILE TRANSFERRING THE BATTERY AND REPLACING THE LEADS. THE PHYSICIAN'S STAFF STATED THAT, PER THE NOTES, A NEW SET OF LEADS WERE CONNECTED INTO THE GENERATOR AND NO IMPEDANCE ISSUES WERE FOUND. THE AREA WAS IRRIGATED. NO OTHER INFORMATION WAS PROVIDED TO CLARIFY WHAT WAS MEANT BY THE PATIENT WAS BURNT AS THIS WAS ALL THE INFORMATION THAT WAS AVAILABLE. IT WAS UNKNOWN IF THE BURN REFERRED TO ELECTROCAUTERY OR IF ELECTROCAUTERY WAS USED DURING SURGERY. IT WAS SAID THAT A VIDEO SWALLOW STUDY WAS PERFORMED WHICH WAS NEGATIVE FOR ASPIRATION. DIAGNOSTICS WERE ALL OK. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243991 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 201419

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR