RESTORE ULTRA
Report
- Report Number
- 3004209178-2014-12326
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Report Date
- June 9, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V009278, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS), IN THEIR BACK, WOULDN¿T CHARGE UP ¿AT ALL¿. IT WAS NOTED THAT WHEN THE PATIENT WAS CHARGING LAST WEEK, IT WAS ¿A LITTLE BIT HE COULDN¿T CHARGE¿, THEN THIS WEEK THE PATIENT COULD NOT CHARGE AT ALL. THE PATIENT HAD ALSO TRIED TO CHARGE SATURDAY AND SUNDAY BUT WAS UNABLE TO. IT WAS REPORTED THAT THEIR INS WAS ¿NOW DEAD¿. THE REPORTER WAS NOT WITH THE PATIENT AND DID NOT KNOW WHAT HAPPENED WHEN THE PATIENT TRIED TO CHARGE. ADDITIONAL INFORMATION RECEIVED ON THE SAME DATE REPORTED THAT THE INS BATTERY ON THEIR LEFT SIDE WON¿T CHARGE. THE PATIENT STATED THAT WHEN THEY WERE CHARGING THEIR INS LAST WEEK, THEY HAD A ¿LITTLE TROUBLE¿ AND THAT THE RECHARGER SCREEN WOULD GO BLANK. THE PATIENT THEN PLUGGED THE RECHARGER INTO THE WALL AND SAW THE RECHARGER RECHARGING SCREEN. WHEN THE PATIENT PLACED THE ANTENNA OVER THE INS AND PRESSED THE START CHARGE BUTTON, THEY SAW A REPOSITION ANTENNA SCREEN ON THE RECHARGER. THE PATIENT STATED THAT THEY STARTED TO SEE THIS SCREEN LAST WEEK. IT WAS NOTED THAT THE LAST TIME THE PATIENT HAD CHARGED THE INS WAS A COUPLE OF WEEKS AGO AND THAT THEY CHARGED THE DEVICE ON A REGULAR BASIS. IN ADDITION, THE PATIENT DID NOT FEEL ANY STIMULATION. THE PATIENT ALSO STATED THAT WHEN THEY WERE CHARGING THE STIMULATION WAS OFF BUT THAT THEY FELT ¿A LITTLE BIT OF A SHOCKING SENSATION¿. THE PATIENT WAS ALSO UNABLE TO COMMUNICATE WITH THEIR INS USING THE PROGRAMMER UNIT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING PROBLEMS WITH THE RECHARGER FOR THE PAST COUPLE FOR WEEKS. THE FRIEND/FAMILY MEMBER WAS NOT SURE IF THE PATIENT'S INS WAS DEPLETED TO THE POINT THAT IT COULDN'T CONNECT WITH THE RECHARGER OR IF IT WAS THE PATIENT'S RECHARGER. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A COMMUNICATION PROBLEM. THE PATIENT WAS REPORTEDLY HAVING AN ISSUE WITH THE RECHARGER (INSR). THE GREEN LIGHT WAS SEEN ON THE DESKTOP CHARGER. THE REPOSITION ANTENNA SCREEN HAD BEEN REPORTEDLY SEEN FOR A COUPLE WEEKS. THE LAST TIME THE PATIENT WAS ABLE TO CHARGE WAS ABOUT 3 WEEKS AGO. ABOUT 2 WEEKS AGO, THE PATIENT WAS FEELING A STEADY SHOCKING SENSATION AND THEN THE SENSATION WENT AWAY AND THE PATIENT WASN'T ABLE TO CHARGE. THE PATIENT USUALLY CHARGED EVERY 2-2.5 WEEKS. A POOR COMMUNICATION SCREEN WAS SEEN. THE PATIENT'S THERAPY WAS NOT WORKING AS EXPECTED, AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT WAS NOT ABLE TO COMMUNICATE BOTH WITH THE PATIENT PROGRAMMER AND THE INSR. THE PATIENT WAS REPORTEDLY UNABLE TO FEEL STIMULATION. THE PATIENT CONTACTED THE HEALTH CARE PROVIDER'S (HCP) OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382711 | 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 | 00064 YR |