FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1031787
·
Received April 21, 2008
Report
- Report Number
- 2029203-2008-00291
- Event Type
- Injury
- Date Received
- April 21, 2008
- Date of Event
- April 14, 2008
- Report Date
- April 14, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED PRODUCT WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE PATIENT'S TRIAL LEADS WERE EXPLANTED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR LEAD | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2138-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SC-2138-50| EXPLANTED: |