FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 3246821
·
Received July 25, 2013
Report
- Report Number
- 3004209178-2013-12285
- Event Type
- Injury
- Date Received
- July 25, 2013
- Report Date
- July 1, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 377760 LOT# V002341, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 355029 LOT# N0044140, IMPLANTED: 2006 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED BECAUSE, THE ¿SCIATICA NERVE¿ WAS ¿FIXED¿ AND IT WAS NO LONGER NEEDED. NOW THE NERVE WAS ¿MESSED UP AGAIN.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348519 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |