ITREL 3
Report
- Report Number
- 3004209178-2013-00543
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- May 5, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT# N208353, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
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ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A DOCTOR¿S APPOINTMENT THE DAY OF THE REPORT AND THE MANUFACTURER REPRESENTATIVE HAD NOT SHOWN UP. THE PATIENT STATED THAT THE DEVICE WOULD NOT SHUT OFF, THERE WAS A SHORT, IT ¿SHOCKED THE DAYLIGHT OUT OF HIM,¿ AND CAUSED THE DISCOLORATION OF SKIN ON HIS BACK WHICH WAS WHY HE WAS BEING TESTED FOR CANCER. THIS HAD BEEN GOING ON SINCE 2010. LATER THAT DAY THE REPORTER TURNED THE IMPLANT OFF AND THE PATIENT CONTINUED TO REPORT SHOCKING AT THE LEAD AND EXTENSION CONNECTION. THE PATIENT EVEN TURNED STIMULATION DOWN; THE PATIENT FELT THE DECREASE IN STIMULATION BUT KEPT GETTING SHOCKED. THE PATIENT FELT LIKE THE DEVICE WAS TURNING ON WHEN IT WAS OFF. THE PATIENT STATED THAT THE SHOCKING SEEMED TO BE RANDOM. THE PATIENT STATED THAT THE SHOCKING BEGAN IN (B)(6) 2010 WHEN HE WAS SITTING AT HOME AND MOVED IN HIS RECLINER. IT FELT LIKE SOMETHING PULLED AND THAT WAS WHEN THE PATIENT STARTED FEELING SHOCKING. THE SHOCKING WAS IN THE MIDDLE OF THE BACK AND NOT WHERE THE PATIENT FELT STIMULATION. WHEN THE REPORTER RAN AN IMPEDANCE CHECK AND THE PATIENT LEANED FORWARD HE GOT SHOCKING AND JOLTING. THE IMPEDANCE MEASUREMENTS WERE NORMAL BUT THERE WERE SOME ¿???¿ IN THE RESULTS. THE QUESTION MARKS APPEARED WHEN THE PATIENT BENT FORWARD BUT NOT WHEN HE LEANED BACK. THE PATIENT ALSO FELT SHOCKING IF THE REPORTER INCREASED VOLTAGE FOR IMPEDANCE TESTING. THE BATTERY LONGEVITY WAS CHECKED AND IT WAS OKAY. THE PATIENT COULD NOT GET APPROVAL FOR A REVISION OR REPLACEMENT OF THE SYSTEM AS THE X-RAYS AND IMPEDANCES SHOWED NO ISSUE. FURTHER IN THE DAY IT WAS REPORTED THAT THE PATIENT ALSO RECEIVED A SHOCKING FEELING AFTER WALKING THROUGH A SECURITY SCREENER AT A STORE. IT WAS ALMOST AS IF THE IMPLANT HAD TURNED ON BY ITSELF. THE STATUS OF THE REED SWITCH WAS CHECKED AND FOUND TO BE ON. THE REPORTER DISABLED THE SWITCH AND TURNED IT OFF. THE REPORTER THOUGHT THE SHOCKING IN THE MIDDLE OF THE PATIENT¿S BACK COULD BE AN ANATOMICAL ISSUE, SUCH AS IRRITATION FROM THE LEAD AND EXTENSION, HOWEVER WHEN STIMULATION WAS ON THE HURTING INCREASED. THE PATIENT NOTED THAT THE NORMAL STIMULATION FEELING WAS FROM HIS CHEST DOWN TO HIS FEET. THE PATIENT ONLY RAN THE STIMULATOR AT NIGHT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE DID NOT "CUT ALL THE WAY OFF". IT WAS STATED THAT WHEN THE DEVICE WAS OFF THE PATIENT HAD A "BURNING SENSATION FROM CURRENT GOING THROUGH THE WIRES". WHEN THERAPY WAS ON THE PATIENT WOULD GET SHOCKED "WITH HARDLY ANY MOVEMENT". IT WAS STATED THAT THE PATIENT FEELS IT MOST IF HE'S "UP AND WALKING AROUND". THE PATIENT HAD A LEAD REVISION (REFER TO MANUFACTURING REPORT # 3004209178-2011-09254 FOR INFORMATION ON THE LEAD REVISION) AND STIMULATION WAS "FINE FOR ABOUT ONE MONTH" AFTERWARD AND THEN PATIENT STARTED TO FEEL SHOCKING. IT WAS STATED THAT IF THE PATIENT LAYS DOWN WITH THERAPY ON AND HAS HIS BACK "ARCHED" AND THEN SLOWLY BRINGS IT DOWN, HE IS ABLE TO LAY AND SLEEP. IT WAS NOTED THAT IF THE PATIENT MOVES AT ALL DURING THE NIGHT HE WOULD GET SHOCKED. IT WAS STATED THAT THE PATIENT DID NOT USE HIS THERAPY MUCH DURING THE DAY BECAUSE HE GETS SHOCKED MORE WHEN HE'S MOVING. IT WAS REPORTED THAT THE PATIENT WANTED HIS DOCTOR TO DO A REVISION. IT WAS STATED THAT THE LEAD WIRES "LOOKED FINE" ON THE X-RAY. THE DEVICE WAS TESTED BY A COMPANY REPRESENTATIVE AND HE "COULD NOT FIND ANYTHING WRONG WITH THE DEVICE". IT WAS STATED THAT "THE TESTING DID NOT PICK UP A SHORT IN THE SYSTEM". IT WAS REPORTED THAT ON THE X-RAYS "IT LOOKS FINE" AND THERE WERE NO CRACKS IN THE LEAD WIRE AND YOU COULD NOT SEE THE INSULATION. IT WAS REPORTED THAT WHEN STIMULATION WAS ON IT WAS "VIGOROUS" AND THE PATIENT "FELT GREAT". IT WAS STATED THAT IT FELT "VIGOROUS BECAUSE HE WAS SO TENSE". IT WAS REPORTED THAT IT DID NOT HURT THE PATIENT AND IT FELT GREAT TO BE ABLE TO RELAX. IT WAS REPORTED THAT THE COMPANY REPRESENTATIVE CAME TO THE CONCLUSION THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT TURNING OFF ALL THE WAY. IT WAS STATED THAT THE INS "SENT THE PATIENT TO THE EMERGENCY ROOM (ER)". THE PATIENT'S CHEST MUSCLES "TENSED UP" SO TIGHTLY THAT HE COULD NOT BREATH. IT WAS REPORTED THAT THE PATIENT HAD THEIR HEART TESTED AND "EVERYTHING WAS FINE". IT WAS STATED THAT THIS HAS "HAPPENED A FEW TIMES" SINCE THEN. IT WAS NOTED THAT THE PATIENT REFUSES TO GO BACK TO THE ER FOR THAT. IT WAS STATED THAT THE PATIENT "JUST NEEDED TO SIT BACK AND RELAX AND BREATH FOR 1.5 HOURS". ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD SHOCKING, BUT THE CURRENT IMPEDANCES MEASUREMENTS WERE "NORMAL". IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING A "HARD TIME" WITH THE STIMULATOR. IT WAS STATED THAT THE PATIENT HAD A "SHORT" IN HIS BACK, BUT IT DID NOT SHOW UP ON THE TESTING DEVICES. IT WAS NOTED THAT THE PATIENT HAD BEEN "ZAPPED" IN THE BACK WITH THE STIMULATOR, BUT THE STIMULATOR WAS OFF. IT WAS REPORTED THAT IT HAD BEEN "PROVEN" THAT THE BATTERY DOES NOT SHUT DOWN ALL THE WAY WHEN IT WAS TURNED OFF. IT WAS REPORTED THAT THE PATIENT WENT TO THE ER BECAUSE OF THIS. IT WAS REPORTED THAT THE PATIENT'S CHEST MUSCLES CONTRACT AND TENSE UP SO MUCH THAT HE CANNOT BREATH. IT WAS STATED THAT THIS HAPPENED TWICE. IT WAS REPORTED THAT THE PATIENT WENT TO THE ER IN (B)(6) AND IT HAPPENED IN (B)(6). IT WAS REPORTED THAT THE PATIENT HAD HEART TESTS IN THE ER AND HIS HEART WAS "FINE". IT WAS STATED THAT THE PATIENT FEELS LIKE HE IS "BEING STUCK WITH AN EXTENSION CORD" WHEN HE MOVES. IT WAS NOT CLEAR WHAT THIS MEANT. IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS OFF, BUT HE WAS FEELING "CURRENT" IN HIS BACK. IT WAS NOTED THAT THE PATIENT WAS NOT AROUND ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS REPORTED THAT THE PATIENT STARTED HAVING THESE ISSUES IN (B)(6) 2010. IT WAS REPORTED THAT WHEN THE PATIENT MOVES, BENDS, OR TWISTS HE GETS SHOCKED AND THE "ZAP HAS DROPPED HIM TO HIS KNEES SEVERAL TIMES". IT WAS REPORTED THAT A COMPANY REPRESENTATIVE DID "TESTING" BUT COULD NOT DETECT A PROBLEM WITH THE SYSTEM. WHEN THE REPRESENTATIVE DID "TESTING" HE TURNED ON THE CLINICIAN PROGRAMMER AND THE PATIENT "JUMPED AND GOT ZAPPED". THE PATIENT COULD TELL THE CLINICIAN PROGRAMMER WAS ON BECAUSE HE FELT A ZAP. IT WAS STATED THAT THERE WERE NO KNOWN FALLS OR TRAUMAS. IT WAS NOTED THAT THE PATIENT HAD X-RAYS AND A CT SCAN. IT WAS STATED THAT WHEN THE X-RAYS WERE REVIEWED THEY CONFIRMED THAT THE LEADS WERE CONNECTED, BUT THEY HAVE NOT COMMENTED ON FRACTURES OR FRAYS IN THE LEAD. IT WAS STATED THAT THE PATIENT'S TAKE "SOMA", A MUSCLE RELAXER, AND IT "PUTS THE PATIENT TO SLEEP". IT WAS STATED THAT SOMA HELPS, BUT THEN THE PATIENT GET SLEEPY. IT WAS NOTED THAT THE PATIENT CAN ONLY RELAX WHEN HE LAYS DOWN AND ARCHES HIS BACK
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 'SHORT WITH THE WIRES IN MY BACK' WITH THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE 'TEST CAN NOT PICK IT UP' AND X-RAYS SHOWED THE 'WIRES' ARE CONNECTED BUT 'WILL NOT PICK UP THE PROTECTION AROUND THE CONNECTION.' THE PATIENT FELT A 'MILD CURRENT FLOWING' EVEN WHEN THEY DO NOT HAVE THE INS TURNED ON. THE PATIENT CONFIRMED THE SENSATION DESCRIBED AS 'GETTING ZAPPED' IN THEIR BACK. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY NOTICED THE REED SWITCH WAS ON, SO IT WAS TURNED OFF. THE REPORTER INTENDED TO TALK TO THE PATIENT¿S DOCTOR ON FURTHER STEPS THAT NEED TO BE TAKEN. THE PATIENT HAD A GREAT WEEKEND EVEN THOUGH THE DEVICE JOLTED HIM EVERY SO OFTEN, BUT SO FAR SO GOOD.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THE DEVICE OR THERAPY BUT HAD SOUGHT FURTHER HELP. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A PROBLEM WITH THE LEAD IN THEIR BACK AND IT KEPT ¿ZAPPING¿ THE PATIENT. IT WAS NOTED THAT THIS HAD BEEN GOING ON FOR THREE YEARS NOW. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) LOOKED AT THE PATIENT¿S BACK ABOUT TWO WEEKS AGO. IT WAS NOTED THAT WHEN THE HCP PUT THEIR FINGER ¿ON THERE, IT HURT.¿ IT WAS NOTED THAT WHEN THE HCP PUT THEIR FINGER ON THE PATIENT¿S BACK IT WAS SHOCKING THE PATIENT THEN. IT WAS NOTED THAT THE PROGRAMMER DID NOT TURN THE BATTERY CURRENT ALL THE WAY OFF. IT WAS NOTED THAT THE PATIENT ALWAYS HAD A CURRENT GOING THROUGH THOSE LEADS. IT WAS NOTED THAT THE PATIENT HAD ALREADY HAD IT TESTED. IT WAS NOTED THAT THE HCP TOLD THE PATIENT THAT THE SKIN WAS DISCOLORING. IT WAS NOTED THAT THE HCP WAS CONCERNED OF IT HAVING CANCER THERE NOW. IT WAS NOTED THAT THE PATIENT HAD TO GO HAVE A BIOPSY TO SEE IF IT HAD CANCER IN IT. IT WAS NOTED THAT CURRENT HAD BEEN GOING THROUGH THERE FOR 3 YEARS. IT WAS NOTED THAT THE PATIENT WAS TRYING TO GET IT REPLACED BUTWORKERS COMP DID NOT SEE A PROBLEM WITH IT. IT WAS NOTED THAT THE HCP HAD SUGGESTED REPLACING IT. IT WAS NOTED THAT THE PATIENT AND DOCTOR WANTED TO HAVE THE DEVICE REPLACED. IT WAS NOTED THAT A MANUFACTURER REPRESENTATIVE HAD TESTED THE LEAD IN JUNE. IT WAS NOTED THAT THE REPRESENTATIVE WROTE A LETTER THAT IT WAS NOT WORKING RIGHT. IT WAS NOTED THAT THE BATTERY WAS NOT TURNING ALL THE WAY OFF. IT WAS NOTED THAT EVERY NOW AND THEN IT STARTED BURNING THE PATIENT ON THE BACK. IT WAS NOTED THAT SOMETIMES IT GOT SO BAD IT BROUGHT THE PATIENT TO THEIR KNEES. IT WAS NOTED THAT THE PATIENT REPORTED THEY WERE FEELING IT RIGHT NOW IN THE BACK. IT WAS NOTED THAT THE PATIENT HAD THE LEADS TESTED BUT THEY DID NOT FIND ANY LEAKAGE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE COULD NOT PICK UP ANY CURRENT GOING OUT. IT WAS NOTED THAT IT WAS NOT SHOWING WHERE IT WAS GOING. IT WAS NOTED THAT THE PATIENT COULD USE THE DEVICE AT NIGHT. IT WAS NOTED THAT THE PATIENT HAD TO ARCH THEIR BACK. IT WAS NOTED THAT IT WAS DESIGNED TO HELP THE PATIENT WITH FOOT PAIN. IT WAS NOTED THAT IF IT DID NOT HAVE A SHORT IN THERE IT WOULD WORK. IT WAS NOTED THAT LAST YEAR THE PATIENT FELT THIS THING BURNING IN MY BACK AND PATIENT WAS TAKING SHORT BREATHS. IT WAS NOTED THAT THE PATIENT HAD TO CALL 911 AND GO TO THE ER. IT WAS NOTED THAT THE PATIENT WOULD SEE THE DOCTOR NEXT WEEK.
ALL INFORMATION PRIOR (B)(6) 2012, HAS BEEN REPORTED IN MFR REPORT NUMBER 3004209178-2011-09254, WHICH ADDRESSES THE LEAD REVISION OF 2009. HOWEVER, FURTHER REVIEW INDICATED THAT THE SHOCKING AND JOLTING INFORMATION IN MFR REPORT NUMBER 3004209178-2011-09254 SHOULD HAVE BEEN REPORTED IN A SEPARATE EVENT. AS A RESULT THIS REPORT WAS CREATED. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING AND JOLTING SENSATION WHILE THE DEVICE WAS ON; AND, WOULD 'GET ZAPPED' WHEN HIS CAR WOULD GO OVER A BUMP IN THE ROAD WHILE THE DEVICE WAS OFF. IT WAS REPORTED THAT THE PATIENT COULD ONLY USE STIMULATION COMFORTABLY WHILE LYING DOWN AND IN A PARTICULAR POSITION. OTHERWISE THE PATIENT COULD NOT USE THE STIMULATION DUE TO THE SHOCKING. IT WAS NOTED THAT THE 'ZAPPING' BEGAN AFTER THE PATIENT HAD A LEAD REVISION IN (B)(6) 2009 AND THAT THE 'ZAPPING' IS LOCATED AT THE LEAD/EXTENSION CONNECTION. IT WAS ALSO NOTED THAT THE PATIENT WAS GOING TO HAVE A BACK FUSION PROCEDURE ON (B)(6) 2011. EIGHT MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD A SPOT IN HIS BACK THAT WOULD GET 'ZAPPED' BY THE STIMULATOR IF HE MOVED THE WRONG WAY. THE PATIENT WAS TOLD THAT THERE MIGHT BE SOME LIQUID WHERE THE CONTACTS ARE. THE PATIENT HAD A REVISION TO CORRECT A LEAD MIGRATION AND AFTER THE REVISION IF HE PULLED A MUSCLE IN HIS BACK HE WOULD GET 'SHOCKED AND ZAPPED.' IT WAS FURTHER NOTED THAT CERTAIN MOVEMENTS WOULD CAUSE THE DEVICE TO SHOCK HIM IN HIS BACK. IT WAS NOTED AS 'LIKE BEING ELECTROCUTED.' THE PATIENT ALSO REPORTEDLY HEARD A NOISE IN HIS EARS WHEN THIS WOULD HAPPEN. FOUR MONTHS LATER IT WAS REPORTED THAT THE PATIENT WAS FEELING PAIN AT THE LEAD ENTRY SITE/ MIDLINE OF THE PATIENT'S BACK. IT WAS REPORTED THAT THE PATIENT ONLY FELT THE PAIN WHEN THE STIMULATOR WAS ON. IT WAS NOTED THAT THE PATIENT FELT THE PAIN SINCE '2010 OR RIGHT AFTER THE DEVICE WAS IMPLANTED.' THE PATIENT REPORTEDLY ONLY FELT THE PAIN AT HIGH VOLTAGES. IT WAS NOTED THAT IMPEDANCES APPEARED TO BE NORMAL. IT WAS ALSO NOTED THAT WHEN THE PATIENT WAS PROGRAMMED TO 0+,1- THE PATIENT WOULD NOT HAVE PAIN BUT WOULD FEEL STIMULATION IN HIS RIB. THE PATIENT WAS ALSO PROGRAMMED TO 1+,2- BUT THE PATIENT WOULD GET PAIN AT 'MIDLEVEL AS WELL.' THE NEXT DAY IT WAS REPORTED THAT THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A POSSIBLE REVISION. TWO MONTHS LATER ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS STILL EXPERIENCING SHOCKING AND JOLTING AT THE LEAD/ EXTENSION JUNCTION SITE. IMPEDANCE MEASUREMENTS WERE NORMAL. THE PATIENT DESCRIBED THE ISSUE AS 'RELIEF STIMULATION, SHOCKING, RELIEF, SHOCKING, ETC....' THERAPY IMPEDANCE WITH PROGRAM3.35V/390PW/40HZ 1+,2- WERE 615 OHMS. 80UA. IT WAS NOTED THAT PALPITATION OF THE DEVICE WOULD CAUSE STIMULATION CHANGES. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT FEEL THE SHOCKING AND JOLTING WHEN THE STIMULATION WAS OFF BUT DID FEEL IT WHEN IT WAS ON. IT WAS NOTED THAT AN 'X-RAY HAS BEEN DONE AND INDICATED ALL SYSTEM INDICATED.' IT WAS UNCLEAR WHAT WAS MEANT BY THIS. APPROXIMATELY TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS STILL GETTING A JOLTING AT THE LEAD/EXTENSION CONNECTION SITE WHILE THE SIMULATION WAS TURNED ON. IT WAS NOTED THAT IMPEDANCES READ NORMAL. IT WAS SPECULATED THAT THERE MAY BE FLUID IN THE EXTENSION CONNECTION AND THE PATIENT WAS GOING TO GO SEE HIS HEALTH CARE PROVIDER TO DISCUSS A REVISION.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS VERY AGGRESSIVE AND DISTURBED. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE HAS CHECKED THE DEVICE SEVERAL TIMES AND HAS NOT YIELD ANY RESULTS THE SYSTEM IS MALFUNCTIONING. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE BELIEVES THE SHOCKING IS A MEDICAL ISSUE BECAUSE WHENEVER THE PATIENT LEANS BACK THEY RECEIVE THE SHOCKING. THE MANUFACTURER REPRESENTATIVE BELIEVES THAT A NERVE PINCHES IN A CERTAIN POSITION AT THE SPOT WHERE THE LEAD AND EXTENSION ARE CONNECTED.
IT WAS FURTHER REPORTED THE PATIENT'S UNIT WAS "ACTING UP." IT WAS REPORTED THE PATIENT'S DEVICE WAS OFF AND THAT IT DOES NOT SHOCK THEM "AS BAD" ANYMORE. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE THINKS DURING THE HEALING PROCESS THE "CONNECTION PART GOT PUSHED UP AGAINST A NERVE" AND WHEN THE PATIENT MOVES IT STARTS BURNING IN THEIR BACK. IT WAS REPORTED THAT IF THE UNIT IS ON IT "ZAPS THE PATIENT" AND THEY CAN ONLY USE IT WHEN THEY ARE LYING DOWN IN BED. IT WAS REPORTED THAT PATIENT CANNOT USE THEIR DEVICE WHEN WALKING OR SLEEPING BECAUSE IT WILL ZAP THEM. IT WAS FURTHER REPORTED THE PATIENT WAS IN AN ACCIDENT IN 2007 AND THEIR L5/S1 DISC WAS "GONE" AND IT WAS BONE RUBBING AGAINST NERVES WHICH DESTROYED THE NERVES AND THIS WAS THE REASON FOR THE PATIENT BEING IMPLANTED WITH THEIR DEVICE. IT WAS REPORTED THE NERVE DAMAGE IN THEIR LEGS MAKES IT FEEL LIKE THEY ARE "WALKING AROUND ON NEEDLES." IT WAS REPORTED THE PATIENT HAD RECENTLY MET WITH THEIR MANUFACTURER REPRESENTATIVE AND HAD THREE "TESTS" DONE. PATIENT REPORTED THEY HAVE BEEN FIGHTING WORKERS COMPENSATION AND WAS DISSATISFIED WITH HOW THE MANUFACTURER WAS DEALING WITH THE PATIENT'S INSURANCE. IT WAS ALSO NOTED THE PATIENT HAD CANCER REMOVED FROM THEIR BACK IN (B)(6) 2013. INFORMATION WAS OMITTED PERTAINING TO EVENTS (B)(4) - LEAD MIGRATION/REVISION AND (B)(4) - INS TURNS ON/EMI.
THE PATIENT¿S HEALTH CARE PROVIDER REPORTED ON (B)(6) 2013 THAT SURGICAL INTERVENTION HAS NOT YET OCCURRED BUT WAS PENDING.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO EVIDENCE THAT ANYTHING WAS WRONG WITH THE SYSTEM. IT WAS NOTED THAT IMPEDANCE READINGS WERE NORMAL. THE HCP WAS NOT CONVINCED THAT THERE WAS A DEVICE ISSUE AND HAD NOT ORDERED ANY IMAGING OR OTHER DIAGNOSTICS. THE PATIENT'S INSURANCE DENIED COVERING ANYTHING MORE BECAUSE THERE WAS NO EVIDENCE OF AN ISSUE, ONLY THE PATIENT'S VERBAL COMPLAINTS. THE MANUFACTURING REPRESENTATIVE ATTEMPTED TO REACH OUT TO THE HCP AND LEFT SEVERAL MESSAGES AND WENT TO THE CLINIC TO TRY TO CATCH THE HCP. THE HCP WAS BUSY AND THEY LEFT THEIR CARD. THE MANUFACTURING REPRESENTATIVE HAD BEEN UNSUCCESSFUL IN CONTACTING THE PATIENT'S DOCTOR. THE MANUFACTURING REPRESENTATIVE STATED THEY MET WITH THE PATIENT BUT DID NOT REMEMBER THE DATE. IT WAS NOTED THAT THEY DID NOT LIFT THE PATIENT'S SHIRT TO SEE IF THERE WAS DISCOLORATION. THE MANUFACTURING REPRESENTATIVE STATED THAT HE THOUGHT IF THERE WAS THAT WOULD BE REASON ENOUGH TO PERFORM FURTHER TESTING. THE MANUFACTURING REPRESENTATIVE HAD NOT HEARD A CONFIRMATION ABOUT THE DISCOLORATION FROM THE HCP AND HAD NO INFORMATION ABOUT THE BIOPSY RESULTS. WHEN THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT THEY PALPATED THE AREA WHERE THE PATIENT FELT PAIN. IT WAS NOTED THAT IT WAS NOT ACTUALLY SHOCKING. IT WAS A "JARRING TYPE OF PAIN, SURPRISING, SHOCKED TO FEEL SO MUCH PAIN NOT ACTUAL SHOCKING." THE MANUFACTURING REPRESENTATIVE STATED THAT THIS WAS WHAT THE PATIENT HAD SAID. THE SITE OF PAIN WAS AT THE JUNCTION WHERE THE LEAD CONNECTED TO THE INS. THE AREA HURT EVEN WHEN THE STIMULATION WAS OFF. THE PATIENT DESCRIBED THE SAME PAIN UPON PALPITATION WITH THE STIMULATION BEING OFF. THE MANUFACTURING REPRESENTATIVE "AT BEST GUESS" THE JUNCTION COULD BE SITTING ATOP AN AGGRAVATED NERVE. THE PATIENT STATED THAT THEY HAD NO PAIN WHILE LYING DOWN OR SLEEPING. IT WAS NOTED THAT THIS WAS TRUE BOTH WHEN THE STIMULATION WAS ON AND OFF. THE MANUFACTURING REPRESENTATIVE REPORTED THAT THE BATTERY HAD PLENTY OF LIFE. THE MANUFACTURING REPRESENTATIVE HAD NO FURTHER INFORMATION AND IF THEY WERE ABLE TO GET A RESPONSE FROM THE HCP THEY WOULD CONTACT THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21362 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |