FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 5940302
·
Received September 9, 2016
Report
- Report Number
- 3004209178-2016-18637
- Event Type
- Injury
- Date Received
- September 9, 2016
- Report Date
- September 9, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
AN HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT ALL OF THEIR 2010 PAIN STIM SYSTEM WERE REMOVED ON (B)(6) 2010 SECONDARY TO A PULSE GENERATOR SITE INFECTION.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593135 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |