FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1172086
·
Received September 23, 2008
Report
- Report Number
- 2029203-2008-00570
- Event Type
- Injury
- Date Received
- September 23, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
A REPORT OF A POST OPERATIVE EPIDURAL HEMATOMA WAS RECEIVED. THE PHYSICIAN DECIDED TO IMMEDIATELY EXPLANT THE PRECISION SYSTEM. THE EXPLANT RELIEVED THE HEMATOMA AND THE PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORTION | SC-8120-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MODEL # SC-1110| IMPLANTABLE PULSE GENERATOR |