FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 3604281
·
Received February 3, 2014
Report
- Report Number
- 3004209178-2014-01512
- Event Type
- Malfunction
- Date Received
- February 3, 2014
- Report Date
- January 15, 2014
- 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
PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377745, LOT# V000942, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS VERY "SHORT WAISTED" AND THE POSITIONING OF THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD ALWAYS BEEN AN ISSUE. IT WAS NOTED THE PATIENT KEPT BUMPING IT ON THINGS AND THE INS DIDN¿T "STAY PUT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71111 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |