BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3863831 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01448
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 18, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE TWO SURGERIES SINCE THE (B)(6) 2014 REPLACEMENT SURGERY AS INTERVENTION FOR HER VOCAL CORD PARALYSIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN OBTAINED TO DATE.

    Description of Event or Problem · 1

    NOTES FROM THE PATIENT'S ENT PHYSICIAN WERE RECEIVED THAT REPORTED THAT THE PATIENT'S VOICE QUALITY WAS REMARKABLE FOR LOWER FUNDAMENTAL FREQUENCY WITH MILD ROUGHNESS. THE PATIENT ALSO COUGHED WITH EXERTION AND TALKING AND EXPERIENCED SOME DYSPNEA AND DYSPHAGIA. FLEXIBLE LARYNGOSCOPY WAS PERFORMED WHICH REVEALED THE LEFT TRUE VOCAL FOLD TO BE IMMOBILE AND FORESHORTENED. THERE WAS NORMAL RIGHT VOCAL FOLD MOBILITY. IT INDICATED THAT THERE MAY HAVE BEEN A SUBTLE INJURY FROM HER INITIAL SURGERY AND THE SURGERY REPORTED IN MFR REPORT # 1644487-2014-00873 WORSENED IT. AS TREATMENT, THE PATIENT UNDERWENT TWO MICROLARYNGOSCOPIES WITH INJECTION OF CYMETRA INTO THE LEFT VOCAL FOLD. AFTER THIS, HER VOCAL CORD PARALYSIS RESOLVED. THE MANUFACTURER'S RECORDS OF THE LEAD WAS REVIEWED. THE LEAD PASSED ALL QUALITY AND FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO FURTHER SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED VOCAL CORD PARALYSIS AS A RESULT OF VNS SURGERY. THE PHYSICIAN'S OFFICE REPORTED THAT THE PATIENT WAS SEEN BY AN ENT, BUT NO OTHER RELEVANT INFORMATION WOULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339164 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202593

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R