BEUDAMED
    FDA Adverse Event Summary report: N

    NEURO-CYBERNETICS PROSTHESIS VAGAL NERVE STIMULATOR

    MDR report key: 756912 · Received July 27, 2005

    Report

    Report Number
    MW4003975
    Date Received
    July 27, 2005
    Date of Event
    January 1, 2004
    Report Date
    June 24, 2005
    Manufacturer
    *
    Product Code
    LYJ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THAT SHE HAS A NEURO-CYBERNETICS PROSTHESIS VAGAL NERVE STIMULATOR (VNS) IMPLANTED IN 1995 AND HAS SURGERY TO REPLACE THE BATTERIES IN THE DEVICE IN 2003. SHE STATED IN 2004, SHE BEGAN EXPERIENCING SPEECH IMPAIRMENT, LEFT ARM NUMBNESS AND TINGLING IN THE LEFT ARM. SHE VISITED A PHYSICIAN AND INFORMED HIM OF HER CONDITION AND HE TOLD HER SHE WAS "FAKING IT." SHE STATED SHE HAS INFORMED THE MFR OF HER ILLNESS AND SHE WAS TOLD BY THE MFR THAT THEY WOULD NO LONGER FLY HER FOR VISITS TO SEE A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO-CYBERNETICS PROSTHESIS VAGAL NERVE STIMULATOR * LYJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *