RESTORE
Report
- Report Number
- 3004209178-2014-07616
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Report Date
- April 1, 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# V000795, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IT WAS REPORTED THAT A PATIENT HAD A BURNING SENSATION AT THE BELT LINE, ABOVE THE BELT ON THE RIGHT SIDE. IT WAS STATED THAT IT WAS A SEARING BURN AT THE ¿BOX¿. IT WAS REPORTED THAT THE BURNING WAS AT THE RIGHT HIP AND IT WRAPPED AROUND HIM AND WENT TO THE GROIN. THE PATIENT STATED THAT HE ¿LITERALLY PASSED OUT WHEN TRYING TO STAND STRAIGHT¿. IT WAS STATED THAT THE BURNING SENSATION STARTED 8 MONTHS AGO, AROUND (B)(6) 2013. IT WAS STATED THAT THE STIMULATION CAUSED A JOLTING SENSATION IN HIS RIB CAGE. IT WAS STATED THAT HE COULDN¿T STAND THE STIMULATION UP TO 1 AMP, ¿BEFORE HE FELT LIKE BEING FRIED¿. IT WAS REPORTED THAT AS A RESULT THE PATIENT JUST LET THE SPINAL CORD STIMULATION (SCS) GO DEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239936 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |