FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2181229
·
Received July 27, 2011
Report
- Report Number
- 3006630150-2011-01186
- Event Type
- Injury
- Date Received
- July 27, 2011
- Report Date
- July 6, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE PADDLE LEAD REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DRAINAGE FROM THE LEAD SITE AND WAS PRESCRIBED ANTIBIOTICS. NO CULTURES WERE TAKEN. THE PHYSICIAN BELIEVES THAT THE INFECTION IS NOT DEVICE RELATED. THE PATIENT HAS SINCE HEALED AND DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |