ECHELON MRI SYSTEM

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 02-JUL-2024, FOR MW5156476. REPORTER CALLING BACK TO UPDATE DEVICE AND MANUFACTURER INFORMATION AND PROVIDE OTHER DETAILS. REPORTER STATES SHE CONTINUES TO DEAL WITH PAIN ON A DAILY BASIS. REPORTER STATES SHE IS TRYING TO DETERMINE HOW THE FDA (FOOD AND DRUG ADMINISTRATION) MONITORS MRI DEVICES AND WHO ULTIMATELY REGULATES WHEN THESE DEVICES WHEN THEY ARE OPERATED INCORRECTLY. REPORTER STATES SHE HAS CONTACTED MANAGEMENT AT THE OFFICES WHERE HER MRI WAS PERFORMED, HOWEVER THEY WERE NOT VERY HELPFUL.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 25-JUN-2024, FOR MW5156476. REPORTER CALLING, STATING SHE CONTINUES TO EXPERIENCE ONGOING PAIN AND CONTINUES WITH MEDICAL FOLLOW-UPS, SOME OF WHICH ARE COSTLY AND OUT OF POCKET EXPENSES. REPORTER STATES SHE HAD BLOOD DRAWN TO INVESTIGATE HEAVY METAL IONS IN HER BLOOD AND THESE LABS HAVE COME BACK "ALL NORMAL". REPORTER STATES THE PAIN, NUMBNESS, AND BURNING SENSATION SYMPTOMS SHE IS EXPERIENCING WERE NOT PRESENT PRIOR TO THIS MRI, AND THEY BEGAN THE INSTANT THE MRI WAS STARTED. REPORTER STATES SHE IS FRUSTRATED AND DEALING WITH DAILY PAIN EVER SINCE THIS MRI.

Description of Event or Problem

I HAD GONE INTO (B)(6) IN THE (B)(6) LOCATION FOR AN MAGNETIC RESONANCE IMAGING OF MY RIGHT TIBIA FIBULA. THE REASON FOR THE MAGNETIC RESONANCE IMAGING WAS DUE TO A VERY ISOLATED BRUISING PAIN THAT WAS ON BOTH MY LOWER RIGHT AND LEFT LEGS FOR ABOUT 2 MONTHS, I HAD THE WEEK EARLY DONE AN ULTRA SOUND TO SEE IF IT WAS MY VEINS AND THEY SAW ON THE ULTRA SOUND INFLAMMATION ON BOTH LEGS ( ABOUT THE SIZE OF A QUARTER) WITH NO EXPLANATION AS MY VEINS WERE FINE. GIVEN IT WAS BOTH LEGS- WANTED TO CHECK IT OUT ON A MRI. I HAVE HAD EXPERIENCED MRI'S MULTIPLE TIMES PRIOR FOR A PREVIOUS SACROILIAC INJURY AND THEREFORE KNEW THEY ARE NO BIG DEAL AND CAUSE NO PAIN, JUST LOUD. WHEN I GOT THERE, I DO REMEMBER ASKING ABOUT A ZIPPER OR SOMETHING ON MY JACKET AND TECH SIDE IT WAS FINE. HE WENT OUT TO TELL ME TO ONLY SQUEEZE THE BALL IF A TRUE EMERGENCY, AS IT WOULD RUIN THE ENTIRE TEST IF I SQUEEZED IT. NO ONE EVER SAID THAT TO ME BEFORE, AND SINCE THEN WAS TOLD IT WOULD ONLY RUIN THE ONE PORTION OF THE TEST. HE LOCKED MY RIGHT LEG INTO PLACE, AS THE SCRIPT CALLED FOR ONLY ONE LEG (FOR INSURANCE REASONS) EVEN THOUGH BOTH LEGS HAD THE ISSUE. THE SECOND THE MACHINE TURNED ON, I FELT A SHARP PAIN IN BOTH LEGS, BEST WAY TO DESCRIBE LIKE LIGHTING WAS GOING THRU BOTH LEGS. I WAS SCARED AND CONFUSED GIVEN I NEVER EXPERIENCED BEFORE, (B)(6) WAS WAITING FOR THE FIRST ¿ROUND¿ TO FINISH FOR THE TECH TO CHECK ON ME. HE DID NOT AND STARTED UP THE SECOND ROUND IMMEDIATELY ( I COULD TELL BY THE NOISE STOPPING AND STARTING). ALL PREVIOUS TEST I HAVE ALWAYS BEEN CHECKED ON WITH A SPEAKER TO MAKE SURE I WAS OK AND OF COURSE THE ONE TIME I WAS NOT OK, HE DID NOT CHECK. AFTER THE 2ND ROUND, WHEN IT STOPPED I WAS SCREAMING (B)(6) (HIS NAME) TO GET HIS ATTENTION, AND TOLD HIM I WAS IN EXTREME PAIN. HE SAID I WAS DOING GREAT AND ALL FINE AND I WAS JUST NOT USE TO "HIS MACHINE". WELL, THE PAIN CONTINUED AND I WAS WIGGLING MY TOES DURING THE TEST AS I FELT MY LEGS WERE GOING NUMB, IT THROBBED ALL NIGHT AND (B)(6) CALLED THE NEXT MORNING TO DISCUSS WITH MANAGER. HE THOUGHT I WAS CRAZY AND TOLD ME NOTHING LIKE THIS HAS EVER HAPPENED IN HIS 25 YEARS OF EXPERIENCE AND IT MUST OF BEEN THE WAY MY LEG WAS LOCKED INTO PLACE. HOWEVER, IT STARTED THE SECOND THE MACHINE WENT ON AND TO BOTH LEGS AND ONLY ONE LEG WAS LOCKED INTO PLACE. I FOUND OUT THE MACHINE WAS A GI FIELD 1.5 TESLA HORIZONTAL FIELD. HIGH FIELD MACHINE AND THE OTHER MACHINE I HAD BEEN IN PRIOR WAS A 1.2 TESLA. AFTER THAT DAY- I WAS IN EXTREME PAIN FOR 6 DAYS STRAIGHT AND NOW ALMOST 3 MONTHS WITH THE PAIN THERE ON REST DAYS, THE PAIN VARIES FROM A HORRIBLE BRUISING PAIN DOWN THE SIDE OF MY LEGS, TO THE FRONT OF MY SHINS FEELING LIKE THEY WERE HIT WITH A BASEBALL BAT, TO A BURNING SENSATION , WITH TINGLING. IT IS ALWAYS CHANGING AND USUALLY BOTH LEGS AT THE SAME TIME HAVE THE SAME SENSATION- BUT OCCASIONALLY ONLY 1 LEG AT A TIME. THE MRI ALSO SHOWED I HAD BONE MARROW EDEMA (WHICH MY DOCTOR SAID BASICALLY THE BONES SWELLING- WHICH IS SORT OF WHAT IT FEELS LIKE SOMETIMES). I HAVE SEEN MY RHEUMATOLOGIST, A METABOLIC BONE SPECIALIST, HEMATOLOGIST, ORTHO, NEUROLOGIST AND HAVE FLOWN OUT TO (B)(6) CLINIC. I HAVE HAD BLOOD TAKEN 5 TIMES (ABOUT 50 TUBES WOULD BE MY GUESS), AN EMG, AND X-RAY OF MY LOWER LEGS A URINE TEST AND ALL IS NORMAL, BESIDES MY VITAMIN D WAS HIGH A 96, BUT I WAS JUST TOLD TO LAY OFF TAKING VITAMIN D. EVERYONE IS CONFUSED AND CAN'T EXPLAIN THE PAIN IN MY LEGS OR THE READING ON THE MRI AS WELL. PLEASE NOTE- THIS PAIN I AM LIVING WITH NOW IS NOT THE REASON WHY I WENT INTO THE MRI TO BEGIN WITH! THAT PAIN WAS MUCH MILDER, MUCH MORE ISOLATED AND TOLERABLE- JUST UNUSUAL. THE MOST RECENT TEST I DID WAS FOR HEAVY METAL POISONING (WAITING FOR RESULTS) TO SEE IF MY LEVELS ARE HIGH AND THEREFORE, CAUSED AN ADVERSE REACTION? I WAS HOPING THE PAIN WOULD SLOWLY GO AWAY OVER TIME, BUT WE ARE APPROACHING 3 MONTHS NOW AND I AM GETTING CONCERNED AND SO UPSET I DID NOT SQUEEZE THE BALL TO STOP THE TEST.