FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1040026
·
Received May 7, 2008
Report
- Report Number
- 2029203-2008-00273
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 7, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT REPORTED DISCOMFORT AT THE POCKET SITE. THE SURGEON HAS DECIDED TO EXPLANT THE PT'S SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SC-3138-25| SC-2138-50| SC-2138-70 |