RESTORE SENSOR
Report
- Report Number
- 3007566237-2013-00387
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- January 23, 2013
- Report Date
- December 18, 2017
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THE INITIAL MDR WAS FILED AS MFR REPORT #3007566237-2013-00387. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE #(B)(4).
(B)(4).
(B)(4).
PRODUCT ID 39565, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
(B)(4).
(B)(4)
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CONTINUED TO HAVE PROBLEMS AND WAS AN INPATIENT AT A REHAB FACILITY. THE PATIENT WAS STILL UNABLE TO WALK WITHOUT ASSISTANCE AND CONTINUED TO HAVE NUMBNESS IN HER LEGS. THE PHYSICIAN INDICATED SHE MAY STILL HAVE FOUR TO SIX MONTHS OF RECOVERY AHEAD. THE PATIENT WAS UPSET AND COMPLAINED OF NUMBNESS AND AN INABILITY TO MOBILIZE, BUT DID SAY SHE WAS GETTING SOME GLIMPSES OF FEELING BACK IN HER FEET AND SOME FEELINGS OF PAIN IN HER HIPS. THE NEUROSTIMULATOR HAD NOT YET BEEN ACTIVATED.
FOLLOW UP REPORTED THE PATIENT HAD NOT HAD ANY POSITIVE ADVANCES IN THEIR CONDITION. IT WAS NOTED THE PHYSICIAN SAID IT WAS OK TO ACTIVATE THE PATIENT'S STIMULATOR. THE REPRESENTATIVE WAS SCHEDULED TO MEET WITH THE PATIENT THE FOLLOWING WEEK TO ACTIVATE AND PROGRAM THE DEVICE.
ADDITIONAL INFORMATION INDICATED THE PATIENT HAD BEEN REPROGRAMMED DUE TO SOME MUSCLE PAIN DOWN THE POSTERIOR LEFT THIGH. IT WAS NOTED THAT WHEN THE PATIENT WAS TRANSFERRED FROM THE WHEELCHAIR TO THE EXAM TABLE, SHE TRANSFERRED WITH MORE EASE. THE PATIENT STILL DID NOT HAVE STEADY CONTROL OF BILATERAL LEGS WHEN SWITCHING FROM BACK TO SIDE LYING. THE PATIENT WAS AMBULATING BETTER WITH ASSISTANCE BUT WAS ¿STILL NOWHERE CLOSE TO GOOD.¿ THE PATIENT COULD FEEL GENTLE TOUCHES ON BILATERAL LOWER EXTREMITIES TO THE FEET. THE PATIENT STATED HER LEGS ¿JUST FEEL LIFELESS¿ AND SHE CANNOT TELL WHEN HER FEET ARE ON THE FLOOR. THE PATIENT ALSO COMPLAINED OF POOR MOTOR CONTROL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
FOLLOW UP INFORMATION REPORTED THAT PATIENT MET WITH THE MANUFACTURER'S REPRESENTATIVE AT THE PHYSICIAN'S OFFICE WHERE THE PATIENT WAS SET UP WITH 4 PROGRAMS WHICH RESULTED IN GOOD COVERAGE FOR THEIR PAINFUL AREAS. IT WAS NOTED THAT WHEN THE PATIENT BUMPED INTO THINGS THEY FELT THE SENSATION OF "SOMETHING TOUCHING" THEM WHICH WAS MORE PAINFUL IF THEY BUMPED HARDER. WHEN OBSERVING THE PATIENT MOVE FROM THEIR WHEELCHAIR TO THE EXAM TABLE, IT APPEARED THAT THEY WERE UNABLE TO CONTROL THEIR LEGS OR PLACEMENT OF THEIR FEET AND TRANSFERRED WITH MUCH DIFFICULTY. THE PATIENT STATED THAT THEY COULD NOT TELL IF THEIR FEET WERE UNDER THEM AND HAD TO LOOK TO SEE IF THEIR FOOT TOUCHED THE FLOOR AS THEY DID NOT FEEL IT. WHEN THE PATIENT WAS ASSISTED TO ROLL FROM SIDE TO SIDE, THEY COULD NOT TELL IF THEIR LEGS WERE TOGETHER AND HAD TO BE CAREFUL NOT TO LET ONE LEG LAG BEHIND THE OTHER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED OVER FIVE MONTHS LATER REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF REPORT AT THE DOCTOR'S OFFICE. THE PATIENT CONTINUED TO AMBULATE USING BILATERAL CRUTCHES, BUT NOTABLY MORE QUICKLY AND FLUIDLY THAN THE LAST TIME THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY SAW HER. THE PATIENT CONTINUED TO COMPLAIN OF WEAKNESS AND NUMBNESS IN BILATERAL LEGS. THE PATIENT REPORTEDLY USED TO BE NUMB FORM THE ABDOMEN DOWN TO FEET, BUT AT THE TIME OF REPORT THE NUMBNESS WAS MORE CONCENTRATED IN THE MID-THIGH AREA TO FEET. IT WAS NOTED THAT WHEN EXACERBATED, THE NUMBNESS WOULD GET HIGHER UP TO ABDOMEN UNTIL THE PATIENT WAS ABLE TO REST. THE MANUFACTURER'S REPRESENTATIVE SET UP THE DEVICE COVERING THE PAINFUL AREAS WITH FOUR DIFFERENT GROUPS. THE PATIENT REPORTEDLY STATED THAT IT FELT PRETTY GOOD BUT COULD NOT TELL IF IT WOULD BE OF ANY BENEFIT. WHEN GETTING THE PATIENT TO AMBULATE AROUND THE OFFICE TO ADJUST THE STIMULATOR FOR "UPRIGHT AND MOBILE," THE PATIENT NOTABLY COULD NOT MAINTAIN THE PACE FOR THE DEVICE TO SENSE MOVEMENT. DURING AMBULATION, THE PATIENT REPORTEDLY STOPPED AND HAD A LAPSE OF BODY SPASMS LASTING ABOUT 30 SECONDS. THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY TURNED THE STIMULATION OFF FOR FEAR THAT IT WAS POSSIBLY RELATED, AND IT DID NOT MAKE A DIFFERENCE. THE PATIENT REPORTED THAT SHE HAD THOSE ON OCCASION WITH AMBULATION. THE PATIENT WAS TO TRY GROUPS AND SET UP STRENGTH FOR LYING POSITIONS AT HOME. THE PATIENT WAS REPORTEDLY ADVISED TO CONTACT THE MANUFACTURER'S REPRESENTATIVE FOR ANY FURTHER ADJUSTMENTS AS NECESSARY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW THE COMPANY REPRESENTATIVE THE PREVIOUS DAY AT THE REHABILITATION CLINIC. THE PATIENT WAS STILL IN A WHEEL CHAIR. THE PATIENT REPORTED HAVING MORE "TINGLING" IN HER LOWER EXTREMITIES, AS WELL AS PAIN IN HER FEET. IT WAS NOTED THAT THE PATIENT WAS WALKING "A LITTLE BETTER", BUT STILL COULD NOT AMBULATE WITHOUT PHYSICAL ASSISTANCE.
IT WAS REPORTED THE NIGHT THE PATIENT WAS IMPLANTED WITH A SURGICAL PADDLE LEAD THE PATIENT NOTICED ABDOMINAL PAIN AND ONE OF HER LEGS WAS NUMB AFTER ANESTHESIA. IT WAS NOTED THE NEXT MORNING THE PATIENT EXPERIENCED ABDOMINAL PAIN, NUMBNESS IN BOTH LEGS AND SHE WAS UNABLE TO VOID. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) BELIEVED THERE WAS PRESSURE ON THE PATIENT'S SPINAL CORD. THE HCP REMOVED ADDITIONAL VERTEBRAL BONE/BODY (DOUBLE LAMINECTOMY) THE EVENING AFTER IMPLANT. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD YET TO BE ACTIVATED AT THE TIME OF THE EVENT AND WAS GOING TO BE ACTIVATED AT THE PATIENT'S FOLLOW UP APPOINTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT WAS DOING BETTER, BUT WAS STILL NOT WELL. SHE WAS WALKING SOME WITH WALKER, BUT WITH DIFFICULTY AND NOT WALKING TOO FAR. IT WAS STATED THAT "NUMBNESS CAME AND WENT," REFERRING TO PATIENT'S LEGS. THE PATIENT HAD NOT BEEN USING DEVICE. IT WAS STATED SHE THOUGHT SHE HAD WORKED THROUGH A LOT OF HER FEELINGS OF ANGER AND DESPAIR, BUT SPEAKING TO THE REPORTER WAS BRINGING THE FEELINGS BACK. IT WAS STATED SHE MIGHT NOT BE READY TO START USING THE DEVICE AT THE TIME OF THE REPORT BECAUSE SHE DID NOT WANT TO RELIVE HER PAST FEELINGS OF ANGER AND DEPRESSION. THE PATIENT HAD NOT BEEN HAPPY WITH HER DEVICE WHEN SHE HAD STOPPED USING IT BECAUSE SHE DIDN'T FEEL LIKE IT WAS HELPING HER AS MUCH AS IT DID DURING HER TRIAL.
ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT WALKED WITH EFFORT USING 2 CANES. SHE WAS STILL COMING TO GRIPS WITH HER OUTCOME. IT WAS STATED SHE MIGHT BE READY IN A MONTH OR TWO TO GIVE HER STIMULATOR ANOTHER TRY. SHE WAS GIVEN SOME ADHESIVE PADS TO HELP WITH MAINTAINING SIGNAL.
INFORMATION WAS RECEIVED FROM THE CONSUMER VIA THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS HAVING THE STIM ULATOR TAKEN OUT ON (B)(6) 2017. IT WAS REPORTED THAT THERE SEEMED TO BE A HERNIATED DISC BEHIND THE PADDLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50166 | 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 | 00053 YR | Required Intervention |