RESTORE
Report
- Report Number
- 3004209178-2014-12748
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- June 14, 2014
- Report Date
- June 18, 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
- AL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT HAD BEEN MORE ACTIVE FOR THE PAST WEEK AND WAS FEELING MORE PAIN THAN NORMAL. IT WAS STATED THAT THE PATIENT WAS UNABLE TO FEEL ANY STIMULATION ON (B)(6) 2014. IT WAS STATED THAT THE PATIENT TURNED HER STIMULATION UP AND ¿FINALLY FELT STIMULATION AT 6.0.¿ IT WAS STATED THAT THE PATIENT HAD RAN ERRANDS ¿ALL DAY¿ AND IT WAS ABOUT 6-7 HOURS LATER WHEN THE PATIENT BENT DOWN AND STOOD BACK UP THAT SHE GOT A SHOCK AND HER ¿BODY WENT STIFF AS A BOARD AND SHE COULDN¿T MOVE ANYTHING BUT HER ARMS.¿ IT WAS STATED THAT THE PATIENT TURNED HER STIMULATION DOWN TO ¿1.9¿ AND COULDN¿T FEEL STIMULATION AT THAT LEVEL. IT WAS STATED THAT THE PATIENT HAD BEEN IN PAIN SINCE ¿THE EXPERIENCE.¿ IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014 AND THE PATIENT¿S HEALTHCARE PROVIDER (HCP) WANTED TO ¿GET PICTURES OF THE LEADS.¿
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AFRAID TO GO HIGHER THAN FIVE BECAUSE ¿SHE ONCE DID THAT AND WAS SHOCKED FOR FOUR MINUTES.¿ THE PATIENT NOTED THAT SHE MET WITH THE MANUFACTURER REPRESENTATIVE (B)(6) 2014 THE MANUFACTURER REPRESENTATIVE REPROGRAMMED IT. THE PATIENT REPORTED THAT SHE HAD NO FALLS OR ACCIDENTS. THE PATIENT WAS REDIRECTED TO HCP. IT WAS LATER REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. THE PATIENT STATED IT SHOCKED HER FOR FOUR MINUTES WHICH CAUSED ¿OTHER PROBLEMS.¿ IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE ON (B)(4) 2014. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2014-13923.
IT WAS REPORTED LATER THAT THE PATIENT HAD BEEN SICK AND LOST WEIGHT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN THE FRONT SIDE AND IT HAD FALLEN AND WAS SITTING ON THE PELVIC BONE. THE PATIENT WENT TO THE HOSPITAL, COULDN'T EAT AND WAS THROWING UP, THEY HAD A CT SCAN DONE. THE PATIENT WAS DIAGNOSED WITH BLOCKAGE IN THE ESOPHAGUS AND LESIONS IN THE STOMACH. THE PATIENT WAS INSTRUCTED TO GET AN APPOINTMENT WITH THE HEALTHCARE PROVIDER (HCP). THE PATIENT HAD NOT YET SEEN THE HCP. THE PATIENT CALLED THE OFFICE THE WEDNESDAY PRIOR AND HAD NOT HEARD BACK FROM THE HCP. AT THAT POINT THE PATIENT WANTED TO GET THE SPINAL CORD STIMULATOR (SCS) REMOVED AND HAVE A PUMP PUT IN. THE PATIENT LOVED THEIR MACHINE SCS). THE PATIENT WAS ABLE TO GET OFF ALL MEDICATIONS LIKE MORPHINE, TAKING 10-12 PILLS A DAY. THE PATIENT WAS THEN BACK ON MEDICATION AND THOUGHT THAT MAY BE CAUSING THEM STOMACH PROBLEMS. THE PATIENT MENTIONED THEY RECEIVED A LETTER THAT IT WAS TIME TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HCP OR MANUFACTURER REPRESENTATIVE (REP). THERE WAS AN APPOINTMENT DATE NOTED FOR (B)(6) 2015; THE ISSUE WAS NOT SETTLED. THE PATIENT WAS VERY PLEASED WITH THEIR IMPLANT FOR MANY YEARS AND IT ENABLED THEM TO COME OFF MANY MEDICATIONS. IN (B)(6) 2013 THEIR MACHINE MALFUNCTIONED AND STIFFED THEIR BODY. THEY FELL LIKE A TREE AND HIT THEIR HEAD ON CONCRETE. THE PATIENT WAS BEING SHOCKED FOR ABOUT 3-5 MINUTES UNTIL THEY COULD GET THE MACHINE CUT OFF. FROM THATPOINT ON IT HAD NOT WORKED PROPERLY. THE PATIENT WAS SEEN BY REP'S ABOUT 4 TIMES IN A THREE MONTH PERIOD AND WAS TOLD NOTHING WAS WRONG. THE PATIENT GOT SHOCKED, KNOCKED TO THE GROUND. THE PATIENT WORKED WITH 3-4 MANUFACTURER REPRESENTATIVES AND NEVER FIGURED OUT WHAT HAPPENED. THIS OCCURRED IN 2014. THE INS WOULDN'T CHARGE. THEY WOULD REPROGRAM AND IT WOULD WORK FOR 2-3 DAYS AND THEN STOPPED WORKING. THEY USED IT RARELY. IT WASN'T CHARGING PROPERLY NOR WORKING UNLESS THEY CUT UP TO LEVEL THEY FELT COMFORTABLE WITH. THEN ONE WEEK AFTER THEIR LAST VISIT, THE PATIENT GOT A LETTER STATING IT WAS NEARING TIME FOR A BATTERY REPLACEMENT. THIS UPSET THE PATIENT AS THEY WERE BEING TOLD NOTHING WAS WRONG WITH IT. THE LAST TIME THE PATIENT TRIED TO CHARGE IT WOULD NOT. DUE TO THE INCREASED PAIN DUE TO THE MACHINE NOT WORKING THE PATIENT HAD TO GO BACK ON STRONG MEDICATIONS. THOSE MEDICATIONS CAUSED EXTREME STOMACH ISSUES AND AS A RESULT THE PATIENT LOST 38 POUNDS IN A TWO MONTH PERIOD. THIS CAUSED THE BATTERY IMPLANTED TO DROP AND WAS SITTING ON TOP OF THEIR PELVIC BONE. THEY HAD TO GO TO THE EMERGENCY ROOM WHERE THEY DID A CAT SCAN WITH DYE. THE PATIENT WAS INSTRUCTED TO SEE THE HCP IMMEDIATELY AND IT TOOK 3 WEEKS FOR THE REP AND HCP TO SEE THE PATIENT. THEIR APPOINTMENT WAS (B)(6) 2015. THE PATIENT EXPLAINED AND SHOWED THE REP WHERE THE BATTER WAS LOCATED AT THE TIME OF THE REPORT AND THAT IT WOULDN'T CHARGE. BUT THAT TIME THE HCP HAD LEFT. THE PATIENT WAS TOLD BY THE REP AGAIN NOTHING WAS WRONG AND NO REASON IT SHOULDN'T CHARGE. SO THE PATIENT HAD TO WAIT FOR THE HCP TO RETURN. THE PATIENT INFORMED THE HCP AND REP THEY WANTED THE MACHINE REMOVED. EVEN THOUGH THE MACHINE WAS NOT WORKING MAKING IT IMPOSSIBLE TO SLEEP AND CONSTANTLY DEALING WITH PAIN OF IT SITTING ON THE TOP OF THEIR PELVIC BONE. THE PATIENT WAS INFORMED THEY WOULD HAVE TO WAIT A MONTH TO HAVE IT REMOVED, WHICH TO THE PATIENT WAS UNACCEPTABLE. THE PATIENT SPOKE WITH THE OWNER OF A CLINIC AND THE HCP AGREED TO TRY TO GET THEIR SURGERY SCHEDULED FOR MONDAY(B)(6) . THE PATIENT WAS KEPT WAITING BY THE REPS ON SEVERAL OCCASIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400459 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR |