RESTORE
Report
- Report Number
- 3004209178-2013-07407
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Report Date
- April 19, 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 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 377760 LOT# N0030813, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6),PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377760 LOT# N0027966, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT A PATIENT FELT A SHOCKING OR JOLTING SENSATION. THE REPORTER STATED THAT THE PATIENT WAS HAVING PROBLEMS WITH HIS NECK AND IF HE MOVED A CERTAIN WAY HE GOT "A JOLT OF ELECTRICITY." IT WAS REPORTED THAT SYMPTOMS INCLUDED ACUTE PAIN AND PAIN IN THE PATIENT'S NECK STARTED ABOUT FOUR DAYS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT DIDN'T BELIEVE THAT THE DEVICE WAS CAUSING THE ELECTRIC JOLTING FEELING IN HIS NECK BECAUSE HE TURNED THE THERAPY OFF FOR THREE DAYS AND DIDN'T NOTICE ANY CHANGES. THE PATIENT HAD THERAPY TURNED BACK ON BECAUSE, HE WAS STARTED TO GET SOME NUMBNESS IN HIS FEET WHICH THE DEVICE HELPED COVER. ADDITIONAL INFORMATION HAS BEE REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200789 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |