RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-03162
- Event Type
- Injury
- Date Received
- February 28, 2013
- Report Date
- February 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4).
ADDITIONAL INFORMATION STATED THE PATIENT HAD GREAT STIMULATION THE FIRST WEEK AFTER IMPLANT AND THEN THE BATTERY DIED BEFORE THE WOUND WAS HEALED SO THE PATIENT COULDN'T CHARGE RIGHT AWAY. IT WAS ALSO REPORTED THE PATIENT HAD TROUBLE MAINTAINING COUPLING AND THE HEALTHCARE PROVIDER SUSPECTED THE DEVICE WAS IMPLANTED TOO DEEP. THE PATIENT HAD NOT BEEN ABLE TO CHARGE THE DEVICE FOR THE TWO WEEKS PRIOR TO REPORT BECAUSE THE BATTERY WAS "DISCHARGED" IT WAS ALSO REPORTED THE PATIENT WAS SCHEDULED TO HAVE A REVISION SURGERY TO REVISE THE DEVICE POCKET ON (B)(6) 2013. ADDITIONAL INFORMATION ALSO STATED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE.
IT WAS REPORTED THAT THE PATIENT WAS SWOLLEN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS NOTED THAT THE PATIENT HAD NO COUPLING BARS. IT WAS NOTED THERE WAS A SUDDEN LOSS IN STIMULATION ON (B)(6) 2013. IT WAS REPORTED THAT THE RECHARGER DISPLAYED A TRIANGLE WITH AN EXCLAMATION POINT. IT WAS NOTED THAT THE PATIENT HAD THE WORST SLEEP EVER. IT WAS REPORTED THAT THE PATIENT TRIED TO OVERDOSE WITH PAIN PILLS. IT WAS NOTED THAT THE PATIENT FELL ASLEEP. PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE.
IT WAS REPORTED THAT THE PATIENT WAS CONFUSING COUPLING BARS WITH THE DEVICE CHARGE LEVEL. THE REPORTER STATED THAT THE DEVICE "DIED" ON (B)(6) 2013 AND THE PATIENT HAD BEEN IN PAIN. IT WAS REPORTED THAT THE PATIENT TRIED TO CHARGE FOR TWO DAYS AND THE DEVICE WAS STILL "PRETTY MUCH EMPTY." A WEEK LATER, IT WAS REPORTED THAT THERE WERE COUPLING OR COMMUNICATION ISSUES. THE NEXT DAY, IT WAS REPORTED THE IMPLANT SITE WAS "STILL PRETTY SORE" AND THERE WAS A BUMP ON IT. THE PATIENT WAS ONLY ABLE TO GET TWO OF EIGHT COUPLING BARS. IT WAS NOTED THAT THE PATIENT WAS IN PAIN WITHOUT THE USE OF HER THERAPY SYSTEM. IT WAS FURTHER REPORTED THAT THE DEVICE WAS CURRENTLY OFF. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN CHARGING "RELIGIOUSLY" FOR FOUR DAYS AND THE DEVICE DIDN'T SHOW AN INCREASE IN BATTERY VOLTAGE. THE REPORTER STATED THAT THE PATIENT GOT ABOUT SIX COUPLING BARS FOR ABOUT FIVE MINUTES AND THEN HAD ZERO COUPLING BARS. IT WAS REPORTED THAT THE DEVICE WAS NEVER CHARGED PAST 50 PERCENT. IT WAS LATER REPORTED THAT BASED ON AN X-RAY THE DEVICE DID NOT APPEAR TO BE FLIPPED. FOUR DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS NOTED THAT THE DEVICE RECHARGER WAS CHARGED TO CAPACITY. THE REPORTER STATED THAT THE PATIENT WAS "PLAYING" WITH HER DEVICE AND "OUT OF THE BLUE" SHE STARTED FEELING STIMULATION AFTER SEVEN DAYS WITHOUT STIMULATION. IT WAS REPORTED THAT THE PATIENT WAS VERY HAPPY WHEN SHE WAS FEELING STIMULATION AND IT WAS FEELING GOOD. THE REPORTER STATED THAT THE PATIENT HAD STIMULATION FOR TWO DAYS AND THEN IT STARTED COMING IN AND OUT. IT WAS NOTED THAT WHEN THE PATIENT TRIED TO TURN THE DEVICE ON, SHE SAW MESSAGES ON THE RECHARGER TO RECHARGE THE DEVICE FURTHER. THE REPORTER STATED THAT THE DEVICE SHOWED ONE QUARTER BATTERY CHARGE WITH ONE QUARTER TO ONE HALF FLASHING. IT WAS NOTED THAT THE PATIENT WAS GOING TO CONTACT THE MANUFACTURER REPRESENTATIVE IF THE PROBLEM PERSISTED. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO SEE HER IMPLANTING PHYSICIAN THE FOLLOWING WEEK. FOUR DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS RECHARGING FOR ABOUT 30 MINUTES AND WAS THEN ABLE TO USE HER STIMULATION FOR 1-1.5 HOURS BEFORE NEEDING TO RECHARGE AGAIN. IT WAS NOTED THAT THE PATIENT SAW A POR (POWER ON RESET) CONDITION ON THE RECHARGER AND THEN SHE WASN'T ABLE TO GET THE RECHARGE SCREEN. AFTER USING THE ANTENNA LOCATE FEATURE, THE PATIENT WAS ABLE TO GET FOUR COUPLING BARS AND IT WAS NOTED THAT THIS WAS THE FIRST TIME IN TWO WEEKS THE PATIENT WAS ABLE TO GET THAT MUCH COUPLING. IT WAS NOTED THAT THE PATIENT COULD NOT ADJUST STIMULATION. IT WAS LATER REPORTED THAT THE POR COULD NOT BE CLEARED BECAUSE OF UNSUCCESSFUL CHARGING. THE REPORTER STATED THAT THE PATIENT WOULD GET STIMULATION FOR AN HOUR AND THEN IT WOULD STOP, AND SHE WOULD TRY "PLAYING" WITH THE DEVICE AND STIMULATION WOULD START AGAIN AND THEN STOP. IT WAS NOTED THAT THE DEVICE MAY HAVE SLID DOWN TOO FAR OR BEEN TOO DEEP. IT WAS NOTED THAT THE PATIENT WAS "SCARED" SHE MAY HAVE TO GO IN FOR ANOTHER SURGERY AND WOULD CONTINUE TRYING TO CONTACT HER HEALTHCARE PROVIDER.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION WENT WELL AND THE PATIENT WAS DOING GREAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87089 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |