SURESCAN
Report
- Report Number
- 3004209178-2015-16755
- Event Type
- Malfunction
- Date Received
- August 26, 2015
- Report Date
- August 14, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THEIR DEVICE WASN'T WORKING, AND THEIR DOCTOR'S OFFICE WASN'T BEING HELPFUL WITH THE DEVICE. THE PATIENT FURTHER WENT ON TO STATE I WAS HESITANT TO DO IT AFTER THE TRIAL, AND WHEN I NEEDED TO MAKE THE DECISION WHETHER TO HAVE THE IMPLANT OR NOT, I COULDN'T MAKE UP MY MIND. ONE OF MY CONCERNS WAS WHAT AFFECT IT WOULD HAVE ON MY RESTLESS LEG SYNDROME (RLS) AND MS. THEY ASSURED ME IT WOULDN'T AFFECT MY MS AND IF IT DID BOTHER MY RLS THEN I COULD JUST TURN IT OFF. I FELT VERY UNINFORMED AS TO WHAT IT ALL INVOLVED. I WASN'T TOLD ANYTHING ABOUT CHARGING THE BIG BATTERY EVERY WEEK OR POSSIBLY EVENT TWICE A WEEK. I WASN'T GIVEN ANY INSTRUCTIONS AFTER MY SURGERY. THE GIRL WHO MADE MY APPOINTMENTS INFORMED ME OF MY PHYSICAL LIMITATIONS BUT NOT ANY INSTRUCTIONS ON HOW TO OPERATE THE EQUIPMENT DAILY. I DID GET A COUPLE OF BOOKLETS WITH THE BATTERY CHARGER BUT THE FIRST COUPLE OF DAYS I WASN'T IN ANY CONDITION TO READ ALL THAT INFORMATION AND THEN TO KNOW WHAT EACH OF THE DIFFERENT WORDS MEANT SUCH AS PATIENT PROGRAMMER, RECHARGER, NEUROSTIMULATOR, BATTERY CHARGER-I WASN'T SHOWN ON THE REMOTE THAT ONE BATTERY WAS FOR THE BATTERY CHARGER AND THE OTHER FOR THE REMOTE. I WAS GIVEN THE NAME OF FIVE MANUFACTURER'S REPRESENTATIVES (REPS.) WHO MET WITH MY AFTERWARDS WHEN IT WASN'T WORKING. THEY TRIED BUT EACH TIME I MET WITH THEM THEY HAD ME SITTING ON THE EDGE OF THE BED AND THEN WOULD ASK ME TO STAND UP BUT THAT WASN'T MY PROBLEM WITH IT NOT WORKING-IT WAS WHEN I WAS DOING PHYSICAL LABOR SUCH AS PREPARING MEALS, IRONING, ETC. THEY SHOULD HAVE HAD ME MOVE AROUND A LITTLE AND THEN CHANGE POSITIONS, AND THEN TRY THE EQUIPMENT THEY HAD AGAIN. I ALWAYS GOT IT THROUGH MY LEGS. ALSO, THEY HAD ME CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) WHICH GOES BACK TO THE ORIGINAL SETTINGS AFTER A LITTLE WHILE. I HAD NO IDEA THAT WHEN I WENT TO GET MY HAIR DONE AND I LAID BACK FOR SHAMPOOING THAT I WOULD GET SO MUCH ENERGY THAT I COULDN'T STAND IT. IT WAS GOING ALL THE WAY UP TO MY CHEST AND ARMS-I COULDN'T STAND IT. I HAD TURNED IT OFF BEFORE I LEFT HOME AS I WAS TOLD NOT TO DRIVE WITH IT ON, BUT WHEN I GOT THERE I WAS GOING CRAZY WHEN I LAID BACK. THEN I CALLED IN TO SUPPORT AND THEY SET IT MANUALLY. I SHOULD HAVE BEEN TOLD ALL THESE THINGS AHEAD OF TIME. EACH TIME I WENT I WAS GETTING ALL KINDS OF ENERGY UP MY LEGS AND STOMACH BUT IT WASN'T GETTING MY BACK. AFTER SOME TIME I STARTED CHANGING THE GROUPS AND TRYING THINGS MYSELF EXCEPT I HAD NO CONTROL OVER THE ENERGY GETTING IN MY LEGS VERSUS MY BACK. I HAVE STENOSIS OF THE SPINE AND I AM NOW THINKING MAYBE IT DOESN'T WORK FOR THAT. AT A POST-OPERATIVE APPOINTMENT I SAW A PHYSICIAN'S ASSISTANCE AND A REP. AND AN X-RAY WAS PERFORMED. THE REP. CAME BACK WITH THE RESULTS AND SAID IT HAD MOVED. OF COURSE THAT CONCERNED ME AND ASKED WHAT THEY DO ABOUT IT, BUT THEY DIDN'T KNOW. FINALLY, I GOT A CONSULTATION WITH A PHYSICIAN WHO SAID OH, IT HASN'T MOVED, IT'S JUST A SIDE VIEW. RIGHT NOW, I HAVE NO IDEA IF IT MOVED OR IF IT'S A SIDE VIEW. WHEN THE REP. TOLD ME IT MOVED I GOT EXCITED TO THINK MAYBE THAT IS MY PROBLEM AND IT CAN BE MOVED TO A CORRECT SPOT AND DO SOME GOOD. THE REP. ALSO SAID THAT IT COULD HAVE MOVED ANYTIME, EVEN WHEN THEY MOVED ME FROM THE OPERATING TABLE TO THE BED. AFTER SEVERAL VISITS TO MEET THE REPS. AND GETTING NOWHERE (I AM STILL TRYING THINGS-CHANGING GROUPS, ETC. BUT NOTHING SEEMS TO WORK. I HAVE GIVEN IT EVERY POSSIBLE CHANCE TO WORK AND DO NOT KNOW WHAT TO DO). AT THE TIME OF THE CONSULT WITH THE PHYSICIAN THEY SUGGESTED I GO WITHOUT IT FOR A COUPLE OF WEEKS AND SEE IF I FEEL WORSE (I CAN'T FEEL MUCH WORSE THAN I DO NOW) BUT I HAVE BEEN WILLING TO TRY EVERYTHING WITH NO RESULTS. I REALIZED WHEN I SIGNED UP FOR IT THAT IT WAS A 50% CHANCE OF NOT WORKING, BUT I WAS SO HOPING AND PRAYING FOR RELIEF BUT HAVE NONE.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PATIENT PROGRAMMER WAS NOT WORKING AS WHEN SHE SYNCED IT THERE WAS NO LIGHTNING BOLT. SHE WAS AT 1.10 VOLTS WHEN SHE WENT TO BED AND WANTED TO RAISE IT IN THE MORNING BUT WAS NOT ABLE TO RAISE IT. WHEN SHE CHANGED TO GROUP B AND C, SHE HAD THE SAME PROBLEM. THE PATIENT PROGRAMMER WAS SHOWING THE SCREEN, TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) ON. IT WAS REVIEWED THE INS WAS TURNED OFF, AND THEREFORE, SHE WAS NOT ABLE TO INCREASE. DURING THE REPORT, THE PATIENT USED THE PATIENT PROGRAMMER TO TURN THE INS ON AND WAS ABLE TO INCREASE. THE PATIENT PROGRAMMER WAS WORKING AS INTENDED. THE PATIENT MENTIONED THAT ONE DAY SHE TOUCHED THE BOTTOM BUTTON BY MISTAKE ON THE PROGRAMMER AS SHE WAS TOLD BY PATIENT SERVICES TO NOT TOUCH THE TWO TOP BUTTONS ON THE SIDE WHEN SHE WENT FROM ADAPTIVE STIMULATION TO MANUAL CHANGE. THE MANUFACTURER'S REPRESENTATIVE (REP) HAD TOLD HER IT WAS OK TO TOUCH THOSE BUTTONS. PATIENT SERVICES REVIEWED THE ON/OFF THERAPY AND ON/OFF PATIENT PROGRAMMER BUTTONS. THE PATIENT ALSO REPORTED THE DEVICE NEVER HELPED HER WITH HER PAIN AND SHE HAD A LOT OF PAIN. THE REPS HAD BEEN WORKING ON THE ISSUE. X-RAYS WERE COMPLETED ON (B)(6) 2015 BECAUSE THE THERAPY WAS NOT COVERING THE PAIN. THE PATIENT FELT STIMULATION, BUT NO PAIN RELIEF. IT WAS DETERMINED THAT THE LEADS HAD MOVED. AT THIS POINT DURING THE CALL, THE PATIENT NOTED SHE GOT IT ON 2 VOLTS NOW AND WAS SITTING AND A CHAIR AND WAS FEELING QUITE A BIT OF STIMULATION IN HER LEGS AND NORMALLY SHE DID NOT FEEL ANYTHING AT 2 VOLTS. THE PATIENT THOUGHT THIS COULD HAVE BEEN BECAUSE HER INS WAS OFF UNTIL (B)(6) 2015. IT WAS NOTED THE PATIENT WAS ALSO CONCERNED ABOUT HER INS BATTERY NOT CHARGING AND REPORTED HER REMOTE SHOWED VERY LOW BATTERY NEXT TO THE LIGHTNING BOLT. THE PATIENT STATED SHE PUT IN BATTERIES MULTIPLE TIMES BUT NOTHING HAPPENED. ON MONDAY OR TUESDAY, HER BATTERY SHOWN ABOUT THREE QUARTERS AND NOW IT WAS SHOWING AT HALF. PATIENT SERVICES SUSPECTED THE PATIENT WAS CONFUSED ABOUT HER EQUIPMENT AND REVIEWED THE INS AND PATIENT PROGRAMMER BATTERY ICONS. IT WAS REVIEWED THE PATIENT WAS LOOKING AT THE INS BATTERY ICON. THE PATIENT PROGRAMMER SHOWED LOW INS BATTERY. THEN, THE PATIENT STATED SHE CHARGED THE INS WITH THE RECHARGER AND IT WAS AT 8 BARS. SHE WAS A T 8 BARS THEN IT WENT DOWN TO 2 AND BACK UP TO 4 BARS WHEN CHARGING ON THE WEEKEND. THE PATIENT WAS LYING FOR 2 HOURS. COUPLING BARS WERE NOT MAINTAINING.
THE CONSUMER AND MANUFACTURER REPRESENTATIVE REPORTED THAT THE STIMULATION WAS CHANGING TO SETTINGS OTHER THAN WHAT WAS PROGRAMMED AND IT WAS BECOMING TOO STRONG. THEY ALSO HAD STIMULATION IN AN UNDESIRED LOCATION, UNCOMFORTABLE STIMULATION, AND PAIN. THEY WANTED THE STIMULATION IN THEIR MIDDLE LOWER BACK BUT THEY HAD NOT BEEN ABLE TO GET COVERAGE THERE. THE STIMULATION WAS PRESENT IN THEIR LEGS, FEET, ABDOMEN, AND RIBS. THE PATIENT COULD FEEL THEIR STIMULATION TURNING ON AND OFF. THEY WOULD CHECK THEIR DEVICE WITH THEIR PROGRAMMER WHEN THESE ISSUES OCCURRED AND THE STIMULATION WAS STILL ON. THESE STIMULATION ISSUES WERE OCCURRING DAILY WITH POSITIONAL MOVEMENT. THE ISSUES HAD OCCURRED WHEN THE PATIENT WAS GETTING IN AND OUT OF THEIR CAR AS WELL AS WHEN THEY WENT FROM STANDING TO SITTING. THERE WERE NO FALLS, TRAUMA, OR ELECTRO-MAGNETIC INTERFERENCE RELATED TO THESE ISSUES. ADAPTIVE STIMULATION WAS ENABLED ON THE PATIENT'S DEVICE. THE PATIENT WAS NOT GETTING THE BEST THERAPEUTIC RELIEF BUT ADJUSTED THEIR PARAMETERS AND THE ISSUES PARTIALLY RESOLVED. ADAPTIVE STIMULATION WAS TURNED OFF UNTIL THE PATIENT COULD MEET WITH A MANUFACTURER REPRESENTATIVE. THE PATIENT HAD 3 GROUPS AVAILABLE AND ALL OF THEM HAD ADAPTIVE STIMULATION ACTIVE. ALL PROGRAMS HAD THEIR AMPLITUDE DECREASED AND THEN INCREASED INDIVIDUALLY TO DETERMINE WHAT FELT BEST FOR THE PATIENT. THE FINAL SETTINGS WERE: GROUP A: 2 PROGRAMS: PROGRAM 1 FOR THE RIGHT LEG, PROGRAM 2 FOR THE LEFT LEG AND FEET GROUP B: 2 PROGRAMS: PROGRAM 1 FOR THE LEFT SIDE OF THE BACK, PROGRAM 2 FOR THE RIGHT SIDE OF THE BACK GROUP C: 1 PROGRAM: RIBS, ABDOMEN, STOMACH, AND A LITTLE IN THE BACK BUT NOT MUCH THE PATIENT DECIDED TO LEAVE THEIR DEVICE ON GROUP B SINCE IT GAVE THE BEST RESULT AND WAS COMFORTABLE. THE PATIENT HAD BEEN USING THE STIMULATION OFF BUTTON TO TURN OFF THEIR PROGRAMMER SO THE DIFFERENCE BETWEEN THE BUTTONS WAS EXPLAINED TO THE PATIENT. THE PATIENT WAS GOING TO BE SEEN BY A MANUFACTURER REPRESENTATIVE THE WEEK OF 2015 (B)(6). NO OUTCOME OR INTERVENTIONS WERE REPORTED WITH THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. THE PATIENT'S INDICATION FOR USE WAS NON-MALIGNANT PAIN.
ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED HER STIMULATOR WAS NOT WORKING. THE PATIENT HAD NOT RECEIVED A RESPONDING CALL FROM THE DOCTOR. THE PATIENT HAD AN X-RAY ON (B)(6)-2015 AND WAS TOLD BY A MANUFACTURER'S REPRESENTATIVE (REP) THAT IT HAD MOVED, BUT THE DOCTOR SAID IT HAD NOT MOVED, BUT WAS IN A DIFFERENT ANGLE. THE PATIENT DID NOT TRUST THE DOCTOR AND WANTED TO FIND A DIFFERENT DOCTOR. THE PATIENT WANTED TO KNOW IF HER STIMULATOR WAS NOT WORKING BECAUSE IT HAD MOVED OR IF IT WAS BECAUSE OF SOMETHING ELSE. STIMULATION WAS NOT COVERING THE PATIENT'S BACK PAIN. THE PATIENT DID NOT KNOW WHAT ELSE SHE COULD SAY TO RESOLVE THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT WAS GIVEN NEW PROGRAMS TO TRY AND WOULD REPORT BACK AS NEEDED.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE REP BECAME AWARE OF THE PATIENT'S COMPLAINT ON 2015-08-14. ON 2015-08-19, THE REP SAW THE PATIENT AND DID SOME REPROGRAMMING. ON 2015-09-09, THE REP WAS GOING TO MEET WITH THE PATIENT TO VERIFY THE PROGRAMMING WAS SUCCESSFUL. NO OTHER DIAGNOSTICS HAD BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566567 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR |