FDA Adverse Event
Injury
Summary report: N
LEAD
MDR report key: 829947
·
Received March 19, 2007
Report
- Report Number
- 2182207-2007-00950
- Event Type
- Injury
- Date Received
- March 19, 2007
- Report Date
- January 24, 2007
- Manufacturer
- MEDTRONIC, INC., NEUROLOGICAL DIVISION
- Product Code
- LGW
- PMA / PMN Number
- p840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ROSENOW, MD, ET AL. "FAILURE MODES OF SPINAL CORD STIMULATION HARDWARE." J. NEUROSURGERY: SPINE/VOLUME 5, 2006; 183-190. FOUR CASES OF INFECTION RELATED TO PERCUTANEOUS LEAD (FBSS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD | LGW | LGW | MEDTRONIC, INC., NEUROLOGICAL DIVISION | LEAD | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION MODEL EXTENSION LOT # UNK| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO| LOT# UNKNOWN| EXPLANTED: |