FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1013815
·
Received March 14, 2008
Report
- Report Number
- 2029203-2008-00119
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 15, 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
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO REPORTED UNCOMFORTABLE STIMULATION. THE PATIENT WAS ADMINISTERED IV FLUIDS AND RELEASED. THE PATIENT HAS DECIDED TO EXPLANT THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | AN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | SC-8120-70 |