FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 3546680
·
Received January 2, 2014
Report
- Report Number
- 3004209178-2014-00017
- Event Type
- Malfunction
- Date Received
- January 2, 2014
- Report Date
- December 11, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# V233248, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD FALLEN DOWN THE STAIRS A MONTH AGO. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED FROM HER BUTTOCK TO HER HIP AS A RESULT OF THE FALL. THE INS HAD MOVED ABOUT 6 INCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00038 YR |