RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-12328
- Event Type
- Injury
- Date Received
- July 26, 2013
- Date of Event
- July 3, 2013
- Report Date
- July 3, 2013
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V964123, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3888-33, LOT# V949385, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V871403, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3888-56, LOT# V920378, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).
SUPPLEMENTAL SUBMITTED FOR ADDITIONAL INFORMATION RECEIVED AND FOR THE REMOVAL OF CONCLUSION CODE, THE ADDITION OF CONCLUSION CODE, AND FOR THE ADDITION OF PATIENT AND DEVICE CODES. (B)(4).
(B)(4)
UPON FURTHER REVIEW IT WAS FOUND THAT CONCLUSION (B)(4) NO LONGER APPLIES TO THIS EVENT.
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS DOCTOR OR MEDTRONIC REPRESENTATIVE. THE PATIENT WANTED THE IMPLANT TAKEN OUT.
THE COMPANY REPRESENTATIVE CONFIRMED THAT THE PATIENT HAS A COMBINATION OF EPIDURAL AND PERIPHERAL LEADS. HE HAD NOT BEEN USING THE DEVICE AND REALLY HAD NO INTEREST IN USING IT. HIS PHYSICIAN ASKED HIM TO THINK ABOUT IT AND TO ATTEMPT TO USE IT SO HE CAN DETERMINE IF HE WAS GETTING ANY RELIEF FROM THE DEVICE. HE WAS GOING TO GO HOME AND PROBABLY NOT USE IT AND RATHER WAIT IT OUT TO GET IT REMOVED. IT WAS DETERMINED THAT THE DEVICE WAS NOT JOLTING DUE TO ANY MALFUNCTION BUT RATHER POSTURAL CHANGES AND UNCOMFORTABLE SUBQ STIMULATION WHEN HE REFUSED TO MAKE ADJUSTMENTS. HE HAS AHISTORY OF NON-COMPLIANCE WITH THE THERAPY.
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE SHOCKING STARTED ON (B)(6) 2013 WHEN HE WENT TO REACH FOR THE FLOOR FROM THE COUCH. HE COULD NO LONGER HAVE THE STIMULATION ON BECAUSE OF THE SHOCKING SENSATION IN HIS LOWER BACK. HE HAD AN X-RAY ON (B)(6) 2013 AND HIS HEALTH CARE PROVIDER (HCP) DETERMINED HE HAS TWO BROKEN LEADS THAT WOULD NEED TO BE REPLACED. HE WAS NOT HAPPY.
IT WAS REPORTED THAT IMPLANTED DEVICE WAS SHOCKING THE PATIENT. IT WAS NOTED THAT IT WAS VERY PAINFUL AND THE PATIENT COULD NO LONGER USE IT BECAUSE IT WAS UNCONTROLLABLE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT HAD A LOWER BACK FUSION IN 2007 AND LOWER BACK PAIN SINCE THEN, SO THE STIMULATOR SYSTEM SEEMED TO BE AN EXCELLENT CHOICE. THIS (PREVIOUSLY REPORTED INFORMATION) WAS NOW A MAJOR SETBACK. THE PATIENT NOW FELT THAT IT HAD FALSE PROMISES IN THAT THE MANUFACTURER KNEW OF THESE ELECTRODES AND LEADS CAUSING MAJOR PROBLEMS. IT WAS NOTED THE PATIENT WAS DISABLED ON MEDICARE SINCE 2008 FROM COLON CANCER AND BACK PROBLEMS AND COULD NOT AFFORD TO HAVE THE PAINFUL OPERATION. NOW, THE PATIENT FELT HE HAD BEEN TAKEN ADVANTAGE OF FOR AN EXPERIMENT AS TO HOW THE LEADS BREAK. THE PAIN THAT THE PATIENT WAS IN AT THIS TIME HAD THE PATIENT WONDERING HOW WELL THE SURGERY (IMPLANT REMOVAL) WENT. REFERENCE MEDWATCH SUBMITTED BY THE PATIENT: MW5059410. SEE MANUFACTURER'S REPORTS 3004209178-2015-01352 AND 3004209178-2012-11777 FOR OTHER INFORMATION CONTAINED IN THE VOLUNTARY MEDWATCH MW5059410.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S DEVICE WAS REMOVED ON (B)(6) OF 2013 BECAUSE OF PREVIOUSLY REPORTED OUT OF CONTROL SHOCKING AND CONTINUED LEAD BREAKS. THEY FURTHER NOTED THAT THE DEVICE WAS EITHER IN THE WRONG SPOT OR NOT WORKING AT ALL AND THAT THE LEADS WERE ¿MOVING AROUND AS MUCH AS 6 INCHES¿ FROM WHERE THEY WERE ORIGINALLY PLACED. THE PATIENT STATED THIS WAS CONFIRMED BY X-RAYS. THE DEVICE WAS ALSO REMOVED TO ¿STOP TORTUROUS PAIN¿ CAUSED BY THE ELECTRODES AFTER THE LEADS BROKE. THE UNCONTROLLABLE SHOCKING AND PAIN BEGAN ON (B)(6) 2013 AND OCCURRED UNTIL THE PATIENT WAS ABLE TO GET TO THEIR CONTROLLER TO SHUT THE STIMULATION OFF. AT THE TIME OF THE REPORT ON (B)(6) 2015, THE PATIENT WAS STILL IN PAIN AND SUFFERING FROM THE EXPERIENCE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THREE PAINFUL SURGERIES TO CORRECT EXTREME PAIN CAUSED BY THE ELECTRODES AFTER THE LEADS BROKE. THE SYSTEM WORKED GREAT TO RELIEVE HIS BACK PAIN AND FOR HIM TO MOSTLY TAKE LESS PAIN MEDICINE SUCH AS PERCOCET 10/325. THE PATIENT BELIEVED THE PROBLEM WASN'T JUST THE BROKEN LEADS SHOWN BY AN X-RAY, BUT THE MAIN STIMULATION SYSTEM ITSELF FAILED AND SENT AN OUT-OF-CONTROL SHOCK AND PAIN IMPULSE. ON (B)(6) 2013, THE DEVICE SYSTEM BROKE INSIDE OF HIM AND SHOCKED HIM PAINFULLY AND UNCONTROLLABLY UNTIL HE STRUGGLED TO REACH THE PROGRAMMER TO TURN IT OFF. IF HE HADN'T BEEN ABLE TO REACH THE PROGRAMMER, IT WOULD HAVE BEEN A TORTUROUS PAIN THAT HE COULDN'T HAVE STOPPED UNTIL THE DEVICE WAS TURNED OFF. THE PATIENT BELIEVED THE LEADS WERE MOVING AROUND FREELY AS MUCH AS SIX INCHES OR MORE FROM WHERE THEY WERE ORIGINALLY PLACED. X-RAYS "SHOWED THE SEVERE PAIN" THE MOVEMENT WAS CAUSING HIM. THE DEVICE SYSTEM NEEDED TO BE SURGICALLY REMOVED PERMANENTLY AS HE NEVER WANTED TO BE IN THE PAINFUL SITUATION AGAIN. THE IMPLANT WAS REMOVED ON (B)(6) 2013. FOLLOWING SURGERY, THE PATIENT WAS IN PAIN AND WONDERED HOW WELL THE SURGERY WENT. THE PATIENT WONDERED IF HE WAS CUT TOO MUCH TO TAKE OUT THE BROKEN WIRES. HE WAS STILL HAVING MAJOR PAIN AND SUFFERING FROM THE IMPLANT AND WAS LEFT WITH A FEELING OF HOPELESSNESS AND HELPLESSNESS AS TO HIS FUTURE AND QUALITY OF LIFE. THE "INSUFFERABLE" PAIN HE ENDURED WAS "UNFORGIVABLE." SEE MFR. REPORTS #3004209178-2015-01352 AND #3004209178-2012-11777 REGARDING OTHER SURGERIES THE PATIENT HAD AFTER LEAD ISSUES.
THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 OHMS WITH ELECTRODES 4-7. ELECTRODES 0-3 AND 8-15 WERE WITHIN RANGE. IN (B)(6) 2013 THE STIMULATION IN THE CERVICAL SPINE AND UPPER BACK AREAS STOPPED WORKING. THEN IN (B)(6) 2013 THE STIMULATION STOPPED WORKING ONE SIDE OF THE LUMBAR AREA. IN (B)(6) 2013 HE WAS REACHING ODDLY AROUND THE COUCH TO GRAB SOMETHING AND HE FELT A SURGE OF STIMULATION THAT DROPPED HIM. HE WAS ABLE TO GET HIMSELF TO HIS REMOTE AND TURN THE STIMULATION OFF WHICH HAS REMAINED OFF. THE COMPANY REPRESENTATIVE SAW THE PATIENT ON (B)(6) 2013 REGARDING IF HE WANTED THE INS REMOVED. INITIAL INTERROGATION RECEIVED NO RESPONSE FROM THE INS. THEN THE INS WAS CHARGED FOR 10 MINUTES AND THE INS COULD BE INTERROGATED. PROGRAM 1 WAS AT 7V AND PROGRAMS 2-3 WERE AT 3+V. REPROGRAMMING OF THE STIMULATION WAS OFFERED BUT THE PATIENT WAS GOING ON VACATION AND DID NOT WANT TO DEAL WITH IT. IT WAS NOTED THAT THE THERAPY HAS HELPED HIM TO REDUCE HIS NARCOTIC INTAKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350065 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Required Intervention |