RESTORE
Report
- Report Number
- 3004209178-2014-22001
- Event Type
- Malfunction
- Date Received
- November 20, 2014
- Report Date
- October 31, 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998, LOT# V855145, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT SINCE THE PATIENT¿S LAST REPROGRAMMING SESSION, WHICH WAS 1 TO 1.5 MONTHS AGO, THE PATIENT¿S STIMULATION HAD BEEN ¿CUTTING OUT.¿ THE ¿CUTTING OUT¿ WAS DESCRIBED AS HAVING ¿CUT OUT LIKE AN OLD CAR WOULD, LIKE THE BATTERY CAN¿T KEEP UP.¿ THE PATIENT NEEDED THE STIMULATION TO BE CONSISTENT AND NOT CUT OUT. THE PATIENT¿S STIMULATION WAS SET TO AVERY HIGH INTENSITY AS THE PATIENT HAD A LOT OF PAIN FROM HER 19 PREVIOUS BACK SURGERIES. IF THE PATIENT WOULD TURN THE STIMULATION DOWN, THE STIMULATION WOULD STILL CUT OUT, BUT NOT AS BADLY AS IT WOULD AT A HIGHER STIMULATION. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINCE THE PATIENT'S LAST VISIT IN THE (B)(6) 2014 UNTIL CURRENTLY THE PATIENT INDICATED THAT STIMULATION WAS RANDOMLY TURNING ITSELF OFF. IT HAPPENED FOR ONE TO TWO SECONDS AT A TIME THEREFORE THE PATIENT DIDN'T HAVE ENOUGH TIME TO CHECK IT WITH THE PATIENT PROGRAMMER (PP). IT WAS NOTED IT COULD HAPPEN FIVE TO SIX TIMES A WEEK. THE LAST TIME THE PATIENT WAS SEEN THEY WERE PROGRAMMED WITH FOUR PROGRAMS WITH HIGH SETTINGS 10.3-10.4 VOLTS. IMPEDANCES WERE ASSESSED AT THAT TIME AND CURRENTLY AND WERE WITHIN NORMAL RANGE OF 757-915 OHMS. IT WAS NOTED THAT THE PATIENT HAD LOST ABOUT 50 POUNDS OF WEIGHT AND SHE COULD SEE THE LEADS AND DEVICE. THE PATIENT COULDN'T REPRODUCE THE LOSS OF STIMULATION AND REPORTED THIS HAPPENED RANDOMLY. PALPATION DID NOT REPRODUCE THE LOSS OF STIMULATION. AN X-RAY WAS SUGGESTED. THE PATIENT WAS EXPERIENCING GOOD RELIEF WITH REPROGRAMMING WHICH WAS UNRELATED TO STIMULATION CUTTING OUT. THE MANUFACTURER'S REPRESENTATIVE (REP) HADN'T HEARD FROM THE PATIENT SINCE THE VISIT BUT DID SPEAK WITH THE PHYSICIAN'S ASSISTANT. THE PATIENT WAS GOING TO BE SEEN ON (B)(6) WITH X-RAY OF THE SYSTEM. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY WITH GREATER THAN 50% THERAPY RELIEF. FLUORO. WAS DONE AT THE PATIENT¿S VISIT AND THE SYSTEM WAS INTACT ACCORDING TO THE PATIENT. THE PATIENT CONTINUED WITH SENSING THE SYSTEM CUTTING INAND OUT ALTHOUGH LESS FREQUENTLY PER THE PATIENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING TROUBLE WITH THE BATTERY PERIOD. THE PATIENT HAD DIAGNOSTICS DONE ON THE SYSTEM AND EVERYTHING WAS FINE. BUT THE PATIENT FELT THE DEVICE SHUT OFF FOR 2-4 SECONDS AND THIS HAPPENED RANDOMLY FOR ¿QUITE SOME TIME¿. THE PATIENT HAD STIMULATION ON A ¿10¿ AND HAD TO RUN IT HIGH AND STEADY BECAUSE OF NERVE DAMAGE. THE PATIENT TURNED STIMULATION DOWN WHEN THEY LAID DOWN BECAUSE IT WAS TOO INTENSE. THE STIMULATION DID NOT HELP THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752188 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR |