RESTORE ULTRA
Report
- Report Number
- 3004209178-2015-04821
- Event Type
- Malfunction
- Date Received
- March 17, 2015
- Report Date
- February 16, 2015
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID: 3888-45, LOT# V355428, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V141361V01, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V355428, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V322621, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V355428, IMPLANTED: (B)(6 )2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37754. SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-45, LOT# V355428, IMPLANTED: (B)(4) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V322621, IMPLANTED: (B)(6 )2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V141361V01, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N231804, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, LOT# N231804, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).
(B)(4).
(B)(4).
THE PATIENT REPORTED TWO MONTHS LATER THAT SOME OF HER LEADS WERE NOT WORKING AND THIS WAS DETERMINED BY THE COMPANY REPRESENTATIVE AT HER LAST APPOINTMENT. THE ISSUE WITH THE LEADS STARTED THREE MONTHS AGO. THE PATIENT HAS A LOT OF DISCOMFORT AND IT¿S NOT WORKING. THE PATIENT HAS PAIN THAT COMES BACK AND HAS BEEN THERE FOR THREE MONTHS. WHEN THE PATIENT WOULD CHARGE IT AND EVERYTHING, SHE COULD TELL WHEN CHARGING AND TURNING UP IT WASN¿T WORKING RIGHT. WHEN THE PATIENT TURNS HER HEAD, THAT EVEN HURTS. THE PATIENT¿S NECK IS REALLY THIN AND YOU CAN SEE ALL THE ELECTRODES, DOESN¿T LOOK PRETTY.
IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT STARTING ABOUT 2 MONTHS AGO. THERE WAS ALSO A SHOCKING OR JOLTING SENSATION. THE PATIENT WOULD FEEL ELECTRICAL SHOCKS IN THE HEAD AND NECK. TURNING THE THERAPY OFF WOULD RESULT IN EXTREME PAIN. THIS OCCURRED A COUPLE OF NIGHTS AGO. THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE (REP) AND THEY DISCOVERED THAT OF THE ¿17 LEADS PATIENT HAD IN HEAD NECK AND BACK, 9 ARE BAD.¿ 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.
THE PATIENT REPORTED LESS THAN A MONTH LATER THAT SHE STILL HAS CONCERNS REGARDING HER DEVICE OR THERAPY BUT HAS NOT SOUGHT FURTHER HELP, SHE HAS NO PHYSICIAN YET SINCE RELOCATING. THE PATIENT WAS DEALING WITH ADDED PAIN. THE PATIENT EXPERIENCED NECK AND HEAD PAIN BUT NOT CONSISTENTLY. THE PATIENT WAS NOT SURE IF SHE CAN UNDERGO ANOTHER SURGERY TO REPAIR THE NINE WIRES BECAUSE OF COPD. AN APPOINTMENT DATE OF (B)(6) 2015 WAS NOTED.
THE COMPANY REPRESENTATIVE CONFIRMED THAT THEY MET WITH THE PATIENT IN LATE FEBRUARY. OTHER THAN INTERROGATING AND SPEAKING TO THE PATIENT¿S PHYSICIAN NOTHING ELSE WAS ABLE TO BE DONE. THE PATIENT WAS IN THE PROCESS OF MOVING TO A DIFFERENT STATE WITHIN DAYS OF MEETING WITH HER. THE CAUSE WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179847 | 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 |