BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAGAL NERVE STIMULATOR

    MDR report key: 1162789 · Received September 15, 2008

    Report

    Report Number
    MW5008318
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    March 31, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SISTER HAD A VAGAL NERVE STIMULATOR PUT IN TO CONTROL SEIZURES AND INSTEAD OF DOING THAT, SHE IS NOW HOSPITALIZED IN A PSYCHIATRIC HOSPITAL WITH HORRIBLE ADVERSE REACTIONS. SHE IS A R.N. AND IS NOW LOSING CUSTODY OF HER DAUGHTER, LOST HER JOB, IS LOSING HER HOME WHICH SHE WAS IN THE PROCESS OF BUYING AND ALL BECAUSE OF THE VAGAL NERVE STIMULATOR. SHE HAS DEVELOPED A SEVERE PSYCHOSIS, AND WE ARE NOT SURE SHE WILL EVER BE THE SAME AGAIN. THIS DEVICE HAS DESTROYED OUR FAMILY. THERE IS AN ENTIRE WEBSITE DEVOTED TO PEOPLE WHOSE LIVES HAVE BEEN DESTROYED BY THIS DEVICE!!! REVERSE THE DECISION "RIEGEL VS. MEDTRONICS" AND MAKE CYBERONICS TAKE RESPONSIBILITY FOR PUTTING THIS DEATH DEVICE ON THE MARKET WITHOUT PROPER TESTING. A BILL WAS SUBMITTED TO CONGRESS TO REVERSE THE DECISION AND MAKE CYBERONICS RESPONSIBLE FOR THE DAMAGE THAT IT HAS CAUSED. OR WOULD YOU RATHER WE {AND I MEAN MY FAMILY AND AN ARMY OF OTHERS} SUE THE FDA FOR PUTTING IT ON THE MARKET WITHOUT PROPER TESTING? IT'S YOUR CHOICE. DO THE RIGHT THING. IF WE CAN'T TRUST THE FDA TO DO THE RIGHT THING THEN WHAT GOOD ARE YOU ANYWAY?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGAL NERVE STIMULATOR VNS LYJ CYBERONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S