BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2863594 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03259
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 9, 2012
    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
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD VOCAL CORD PARALYSIS IN HIS LEFT VOCAL CORD, DIAGNOSED BY AN ENT. THE PATIENT HAD RECENTLY SEEN A CHIROPRACTOR, WHO ADJUSTED HIM AND SHORTLY THEREAFTER HE STARTED HAVING ISSUES WITH HIS VOICE. THE PHYSICIAN FELT THAT THE ADJUSTMENT WAS THE CAUSE OF THE ONSET OF THE VOCAL CORD AND HAD OUR DEVICE NOT BEEN PRESENT THIS WOULD NOT HAVE OCCURRED. DIAGNOSTIC WERE WITHIN NORMAL LIMITS AND IT IS UNKNOWN IF THE VOCAL CORD PARALYSIS WAS PRESENT OR WORSE WITH STIMULATION. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF THIS PRIOR TO VNS. INTERVENTIONS TO BE TAKEN ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 984

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention