FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED
MDR report key: 3562242
·
Received January 8, 2014
Report
- Report Number
- 3004209178-2014-00359
- Event Type
- Injury
- Date Received
- January 8, 2014
- Report Date
- December 18, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377860, LOT# V020883, IMPLANTED: 2007 (B)(6), EXPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377860, LOT# V017663, IMPLANTED: 2007 (B)(6), EXPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT 6 WEEKS AFTER IMPLANT OF THE PATIENT¿S OLD IMPLANTABLE NEUROSTIMULATOR (INS), IT WAS EXPLANTED DUE TO SCAR TISSUE BUILD UP. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14416 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Required Intervention |