FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1222019
·
Received November 6, 2008
Report
- Report Number
- 2029203-2008-00846
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A REPORT OF A POCKET SITE INFECTION WAS RECEIVED. THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MODEL # SC-3138-55| MODEL # SC-3138-55| LEAD EXTENSION| LEAD EXTENSION |