RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-03983
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- March 4, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THE CAUSE OF THE EVENT WAS ¿NOTHING/UNKNOWN.¿ IT WAS NOTED IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS REPORTED AN X-RAY AND REPROGRAMMING WERE PERFORMED ON 2013 (B)(6). IT WAS NOTED THE SYMPTOM ASSOCIATED WITH THE EVENT WAS NO BACK PAIN RELIEF. IT WAS REPORTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED THE PATIENT RECOVERED WITHOUT SEQUELAE.
IT WAS REPORTED THAT THE PATIENT HAD USED THE THERAPY FOR A MONTH SINCE IT WAS IMPLANTED. THE REPORTER STATED THAT DEPENDING ON THE PATIENT'S POSITION, THE THERAPY SENT A LOT OF CURRENT AND SHOCKS DOWN BOTH LEGS. IT WAS REPORTED THAT THE PATIENT WAS ON THE TOILET AND FELT A ROLLING SHOCK OR CURRENT IN BOTH LEGS AND THE PATIENT'S HUSBAND HAD TO TURN THE STIMULATION OFF AS THE PATIENT COULDN'T STAND IT AND IT WAS "TERRIBLE." THE FIRST TIME THE PATIENT FELT THE SHOCK OR CURRENT IT WAS "ON AND OFF A COUPLE OF TIMES" AND THE PATIENT LOWERED STIMULATION AND "DIDN'T THINK ANYTHING OF IT." IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT TALKED TO HER HEALTHCARE PROVIDER AND WAS TOLD THAT THE THERAPY MAY NEVER HELP HER LOWER BACK PAIN BECAUSE OF DAMAGED NERVES. IT WAS NOTED THAT THE HEALTHCARE PROVIDER STATED THAT THE DEVICE WAS PLACED WHERE IT SHOULD BE. IT WAS REPORTED THAT THE PATIENT STATED THAT REASON FOR THE IMPLANT WAS TO GET RID OF THE LOWER BACK PAIN AND THE PAIN IN THE LEG WAS INTERMITTENT AND SECONDARY. THE REPORTER STATED THAT THE PATIENT HAD NOT USED THE THERAPY FOR OVER THREE WEEKS AND WHEN THE DEVICE WAS TURNED ON IT WAS FULLY CHARGED BECAUSE THE PATIENT HADN'T USED IT. IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT WANTED THE DEVICE REMOVED. THE REPORTER STATED THAT THE DEVICE DID NOT SOLVE THE LOWER BACK PAIN AND THE PATIENT WAS IN "EXCRUCIATING PAIN." IT WAS REPORTED THAT THE PATIENT WAS VERY ACTIVE AND HAD LOST 18 POUNDS SINCE THE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE DEVICE COULD BE SEEN THROUGH THE SKIN AND THE PATIENT COULD FEEL ALL FOUR CORNERS OF THE DEVICE. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT STATED THAT SHE HAD THE DEVICE SET VERY LOW AT ¿50 OR 55¿ AND SHE COULD BARELY FEEL IT AT THE TIME OF THIS REPORT. THE STIMULATION REPORTEDLY HELPED THE PATIENT ¿A LITTLE BIT¿ BUT IF HER BACK PAIN WAS BAD OR IF SHE WALKED ¿TOO MUCH¿ IT COULD NOT HELP WITH THE PAIN. THE PATIENT STATED THAT IF SHE HAD IT ¿UP MORE THAN 85 ON THE METER,¿ SHE FELT A DEBILITATING SHOCK DOWN HER LEG AND SHE COULDN¿T WALK. THE PATIENT STATED THAT THREE MONTHS PRIOR TO THIS REPORT, SHE WAS ¿STUCK¿ WHEN SHE GOT SHOCKED. THE PATIENT REPORTED AN OVERSTIMULATION SENSATION. THE PATIENT WISHED THAT SHE HAD NOT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED BECAUSE IT HAD NOT HELPED. THE PATIENT REPORTED STIMULATION IN THE WRONG LOCATION; THE PATIENT STATED THAT THE LEAD WAS IMPLANTED IN THE WRONG VERTEBRAE. THE PATIENT STATED THAT IT ONLY WORKED ON HER LEGS, BUT HER LEG PAIN WAS SECONDARY TO HER LOW BACK PAIN AND SHE NEEDED A REVISION. THE PATIENT THOUGHT THAT THE LEAD SHOULD HAVE BEEN ¿UP AN INCH, INSTEAD OF BEING PLACED SO LOW ON THE SPINAL COLUMN.¿ THE PATIENT REPORTED THAT ¿THEY PUT IT IN WRONG.¿ THE PATIENT STATED THAT IT WAS PAINFUL TO SIT IN CERTAIN POSITIONS BECAUSE SHE COULD FEEL PRESSURE AND PAIN FROM IT. THE PATIENT STATED THAT SHE HAD LOST ABOUT 40 POUNDS SINCE IMPLANT AND SHE COULD NOW FEEL AND SEE THE LEAD WIRE. THE PATIENT STATED THAT SHE HAD INCREASINGLY NOTICED THIS SINCE (B)(6) 2013. THE PATIENT PLANNED TO SPEAK WITH HER HEALTH CARE PROVIDER REGARDING REMOVING THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115725 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR |