FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1192109
·
Received October 7, 2008
Report
- Report Number
- 2029203-2008-00622
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 8, 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
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A COMPLAINT OF INFECTION AT THE POCKET SITE WAS RECEIVED. THE INFECTED FLUID WAS BUILDING UP CAUSING CHARGING DIFFICULTIES. THE FLUID WAS DRAINED AND THE PT WAS ADMINISTERED ANTIBIOTICS. THE PRECISION SYSTEM WAS EXPLANTED. IT WAS DETERMINED THE INFECTION WAS MENINGITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | ST LINEAR LEAD| ST LINEAR LEAD |