BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCISION PLUS SPINAL CORD STIMULATOR

    MDR report key: 3872159 · Received June 9, 2014

    Report

    Report Number
    MW5036555
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, I HAD A PRECISION PLUS SPINAL CORD STIMULATOR PUT INSIDE OF MY LEFT SIDE BACK. THE SURGEON TOLD ME THAT I HAD TO GET REPROGRAMED FOR SIX MONTHS. AND BY (B)(6) IT STARTED TO MALFUNCTION, THE PROGRAMMER REPROGRAMED ME AND BY THE TIME THAT I DROVE 36 MILES HOME AND TURNED THE STIMULATOR BACK ON THE SETTINGS HAD CHANGED AND PUT ALL THE STIMULATION IN MY RIB CAGE AND THEN IT STARTED TO TURN ON AND OFF BY IT SELF. I CALLED THE SURGEON AND HE SAID FOR ME TO CALL THE PROGRAMMER. I DIDN'T GET A RESPONSE FROM HIM TILL (B)(6). THEN HE CALLED AND SET UP AN APPOINTMENT TO REPROGRAM AND BY THE TIME I DROVE 36 MILES HOME AGAIN EVERYTHING CHANGED AGAIN. THE STIMULATION WAS JUST IN MY LEGS AND THE REMOTE WOULD NOT HOOK TO HIS COMPUTER AND THE ENGINEERS FROM BOSTON SCIENTIFIC TOLD THE PROGRAMMER TO USE HIS REMOTE TO PROGRAM ME AND THEN TRY TO PROGRAM MINE AFTER THE REPROGRAMMING. AND WHEN I DROVE HOME 36 MILES AND TURNED THE STIMULATOR ON, EVERYTHING CHANGED AGAIN. EVERY REPROGRAMMING, IT GOT WORSE, IT WOULD COME ON AND OFF MORE, BUT WOULD NOT SHOW UP ON HIS COMPUTER THAT IT WAS DOING THAT. I TOLD HIM THAT IT WAS MY BODY AND I KNOW THAT IT WAS GOING ON AND OFF WHICH WAS CAUSING ME TO HURT WORSE AND MAKING MY STOMACH UPSET AND MAKE ME VOMIT. WELL THE PROGRAMMER SAYS THAT IT WAS AN EASY FIX THAT ALL HE HAD TO DO WAS REPROGRAM AGAIN AND SO I LET HIM REPROGRAM AGAIN AND AGAIN AND AGAIN TILL (B)(6) 2014, AT THAT TIME THE SURGEON SAID TO TRY REPROGRAMMING ONE MORE TIME AND THAT ONE JUST ABOUT KILLED ME. BY THE TIME I DROVE 36 MILES HOME AND TURNED THE STIMULATOR BACK ON ALL THE SETTINGS WERE MAXED OUT ON THE STIMULATION, THAT IT STARTED BURNING DOWN MY SPINE AND LEGS AND ARMS AND THE STIMULATION WAS SO HIGH THAT I ALMOST COULDN'T GET IT TURNED OFF BEFORE IT DROPPED ME TO THE FLOOR. I CALLED THE PROGRAMMER AND HE SAID TO USE MAGNETS TO BREAK THE CYCLE OF THE MACHINE. WELL IT'S STILL RUNNING ON A VERY LOW SETTING AND IT'S STILL CAUSING MY BACK TO HURT WORSE AND FEELS LIKE SOMEONE PUTTING A HOT WIRE DOWN MY SPINE AND LEGS. THEN MY LEGS GO NUMB AND FEELS LIKE SOMEONE STABBING MY FEET WITH NEEDLES. GETTING WORSE THE LONGER THAT IT IS STILL INSIDE OF ME. NOW THE SURGEON IS FINALLY GOING TO TAKE THE SPINAL CORD STIMULATOR PLUS OUT ON (B)(6) 2014. CAN SOMETHING BE DONE ABOUT THIS, PLEASE? I'M IN HELL VERY BADLY. THANK YOU. (B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334095 PERCISION PLUS SPINAL CORD STIMULATOR SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC CORP SC-1110-02

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R