FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1222024
·
Received November 6, 2008
Report
- Report Number
- 2029203-2008-00877
- Event Type
- Injury
- Date Received
- November 6, 2008
- Report Date
- October 7, 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 Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A REPORT OF A PRECISION SYSTEM EXPLANT WAS RECEIVED. THE PATIENT COULD NOT REMEMBER ANY DETAILS OF THE EXPLANT AND THE IMPLANTING PHYSICIAN IS NO LONGER IN CONTACT WITH THE PATIENT AND DOES NOT HAVE ANY DETAILS OF THE EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LINEAR LEAD| LEAD EXTENSION |