FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1357314
·
Received April 6, 2009
Report
- Report Number
- 2029203-2009-00723
- Event Type
- Injury
- Date Received
- April 6, 2009
- Date of Event
- March 10, 2009
- Report Date
- March 10, 2009
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP.
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE RELATED AND WAS A SYSTEMIC DISTAL STAPHYLOCOCCUS INFECTION OF THE HANDS AND FEET. THERE WAS NO INFECTION SURROUNDING THE IPG SITE. THE INFECTION WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS. 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 CORP. | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | ST LINEAR LEAD| MODEL: SC-2218-70 |