FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3102520
·
Received May 9, 2013
Report
- Report Number
- 3006630150-2013-00923
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICE WAS FOUND TO BE SATISFACTORY.
Additional Manufacturer Narrative · 1
THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT PATIENT'S LEAD POKED THROUGH THE SKIN. THE PHYSICIAN BELIEVED THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN EXPLANTED THE LEAD AND WAS DOING WELL FOLLOWING THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT PATIENT'S LEAD POKED THROUGH THE SKIN. THE PHYSICIAN BELIEVED THAT IT WAS PROCEDURE RELATED. THE PHYSICIAN EXPLANTED THE LEAD AND WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204264 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2158-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |