FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1940680
·
Received December 22, 2010
Report
- Report Number
- 3006630150-2010-02187
- Event Type
- Injury
- Date Received
- December 22, 2010
- Report Date
- November 24, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG DOCUMENTATION FOR THE EXPLANTED DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICE FOUND THEM TO BE SATISFACTORY. THE EXPLANTED IPG PASSED ALL VISUAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT FOLLOWING AN EXPLANT PROCEDURE (REFER TO MEDWATCH MFR REPORT # 3006630150-2010-00488), THE PT DEVELOPED AN INFECTION. THE PT WENT TO AN UNK PHYSICIAN WHO CONFIRMED THE INFECTION. THE PT IS CURRENTLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |