RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-08564
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 30, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-33, LOT# VA083PY, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# VA04SR3, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# VA04SR3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# VA04SR3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-56, LOT# VA07FKN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT# VA06MG5, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED BY THE PATIENT¿S FRIEND/FAMILY MEMBER THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT NEVER HAD THERAPEUTIC EFFECT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) COVERING HIS NECK SINCE IT WAS IMPLANTED THE PREVIOUS DAY. THE PATIENT WAS USING PROGRAM B (THE PROGRAM THE PATIENT USED DURING THE TRIAL) BUT COULD NOT FEEL STIMULATION EVEN WHEN AMPLITUDE WAS INCREASED TO 10.5 V. ABOUT ONE WEEK LATER THE COMPANY REPRESENTATIVE REPORTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS REPORTED THAT THE PATIENT WENT FROM 75% BATTERY ON (B)(6) 2013 TO DEPLETED ON (B)(6) 2013. THE REPRESENTATIVE CHARGED THE PATIENT¿S BATTERY FOR 25 MINUTES AND THE BATTERY VOLTAGE INCREASED FROM 3.650 V TO 3.705 V. ADDITIONAL INFORMATION FROM THE COMPANY REPRESENTATIVE REPORTED THAT THE RATE OF BATTERY DEPLETION WAS CONSIDERED NORMAL BY THE REPRESENTATIVE AND THE PATIENT¿S PHYSICIAN. THE PATIENT WAS ABLE TO CHARGE NORMALLY. IT WAS NOTED THAT THE PATIENT USES HIGH OUTPUT USING ALL 16 ELECTRODES FOR STIMULATION, WHICH RESULTS IN THE PATIENT NEEDING TO RECHARGE MORE FREQUENTLY. THE PATIENT WAS REPORTED TO BE DOING WELL. IT WAS LATER REPORTED THAT ¿BOTH SIDES¿ WERE GETTING HOT DURING RECHARGING, THE THERMOMETER APPEARS AND THE INS TURNS OFF. INS AND POCKET AREA WERE HOT. THE PATIENT WAS CHARGING IN BED. THE WOUND AND INS WAS CHECKED ON (B)(6) 2013 BY HIS SURGEON AND THE WOUND LOOKED OKAY. HE HAS TRIED INSULATING MATERIAL. HE HAS HAD 3 OR 4 APPOINTMENTS SINCE IMPLANT WHICH WAS NORMAL FOR THE PATIENT¿S DOCTOR. THE INITIAL PROGRAMMING APPOINTMENT WAS ON (B)(6) 2013 AND ADDITIONAL REPROGRAMMING ON (B)(6) 2013. IN THE LEFT BUTTOCK AREA THE RECHARGE COUPLING WAS UNABLE TO GET MORE THAN 4 BARS WHEN PRESSED AGAINST THE SKIN, 2 BARS WITH NORMAL COUPLING. THE RIGHT INS WAS MORE REACTIVE TO THE HOT/TEMPERATURE. THE LEFT SIDE WAS CERVICAL AND THE RIGHT SIDE WAS THORACIC. HE HAS TRIED 2 RECHARGERS WITH SAME RESULTS. THE INS WAS STILL HAVING TROUBLE HOLDING A CHARGE. HE TOOK A WEEK BREAK AND THEN THE DEVICE WAS REPROGRAMMED ON TUESDAY AT 4:30PM. ONLY 2 LEADS AND 4 ELECTRODES WERE USED WITH A SIMPLE BI-POLE OF 450PW, 40 RATE, 3.0V AND 4.2V. THE DEVICE WAS ABLE TO BE CHARGED TO 100% FULL WITHOUT ANY HEATING. THE PATIENT WENT HOME AND USED THE SYSTEM. THERAPY WAS GOOD BUT THE NEXT DAY ON WEDNESDAY AT 11:45 PM THE INS BATTERY LEVEL WAS AT ZERO. IT WAS NOTED THAT THERE HAS NOT BEEN ANY STRIKES WITH THE DEVICE. REFERENCE MANUFACTURER REPORT # 3004209178-2013-08559.
ON (B)(6) 2013 THERE WAS STILL THE CONCERN ABOUT HOW QUICKLY THE INS DEPLETES WHEN OFF AND ON. THE RECHARGER STATS FOR THE PAST SIX RECHARGE SESSIONS SHOWED THE PATIENT WAS USING THE RECHARGER TO CHECK THE INS CHARGE STATUS AND NOT ALWAYS TO RECHARGE. THE RECHARGE STATS PROVIDED PERIODIC CHECK OF THE INS BATTERY VOLTAGE WHICH ALLOWED AN ASSESSMENT THAT THE INS WAS NOT ABNORMALLY LOSING CHARGE WHILE OFF. THERE WAS SOME DEPLETION BUT WAS IN AN AREA OF 0.0005 V OVER MANY HOURS. THE RECHARGE STATS ALSO SUPPORTS THAT THE ¿RAPID DEPLETION¿ OF THE INS WAS LIKELY NORMAL DEPLETION. THE GROUP IMPEDANCE MEASUREMENTS FOR D1=269 OHMS, 15.419MA; D2=279 OHMS, 9.989MA AND D3=291 OHMS, 13.098MA. THE DEVICE WOULD DEPLETE IN A COUPLE DAYS. THE DEVICE WAS PROGRAMMED IN AN EFFORT TO FIND PROGRAMMING WITH LESS ELECTRODES AND LOW PARAMETER WHILE MAINTAINING THERAPY. IMPEDANCE MEASUREMENTS WITH ALL PAIRS WITH REFERENCE 0 WERE BETWEEN 500 AND 800 OHMS WITH NO INDICATION OF OPEN OR SHORT CIRCUITS. IT WAS THOUGHT THAT LEAD 1 WAS BETTER THAN LEAD 2 BECAUSE LEAD 2 WAS A LITTLE HIGH. THE PATIENT NEEDED HIGHER PARAMETERS AND A MINIMUM OF 3 CONTACTS TO GET REASONABLE THERAPY FOR ONE LEAD. THE FINAL PROGRAMMING WAS TO E1= 1 ANODE, 1 CATHODE, 4.5V, 660PW, 40 RT, 636 OHMS AND E2= 1 ANODE, 2 CATHODES, 10.0V, 660PW, 40 RT, 364 OHMS. THESE PARAMETERS WILL DEPLETE THE INS IN ABOUT 24 HOURS. THE PATIENT HAS BEEN APPROVED BY HIS SURGEON FOR DEVICE REPLACEMENT. THE PRIOR PROGRAMS USED ALL 16 ELECTRODES. IF THE PATIENT USES THE RECHARGER ON ONE OF HIS INSS HE WOULD NOT BE ABLE TO USE THE PATIENT PROGRAMMER ON THE OTHER INS AT THE SAME TIME. IT WAS CLARIFIED THAT THERE WERE NO APPARENT MALFUNCTIONS. THE PATIENT WENT HOME AND FULLY CHARGED ON (B)(6) 2013. THE BATTERY WAS DOING MUCH BETTER AFTER HIS LAST PROGRAMMING SESSION. IT WAS ALSO NOTED THAT A FEW NEW PROGRAMSWERE ADDED. HE HAS IMPROVED SINCE REPROGRAMMING AND DOES NOT WANT TO UNDERGO SURGERY AT THIS POINT.
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT¿S PLANNED SURGERY WAS ON HOLD AS IT WAS NOTED THEY WERE GETTING ¿GOOD RESULTS¿ NOW. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS CONFIRMED THAT THE PATIENT HAS EXTREMELY LOW IMPEDANCE VALUES ACROSS THE LEAD COMBINATIONS AND PROGRAMS USED. THERE WAS SOME DISTANCE BETWEEN THE LEADS AND THE PROGRAMS ARE SET GOING LEAD TO LEAD. THE PATIENT WAS SCHEDULED TO HAVE THE INS REPLACED AND LEAD REVISED FOR BETTER TREATMENT ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244933 | 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 | Required Intervention |