FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1871057
·
Received October 12, 2010
Report
- Report Number
- 3006630150-2010-01723
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- August 31, 2010
- Report Date
- September 14, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES INVOLVED IN THE EVENT WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MFG DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO PAIN AT THE BATTERY SITE. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
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 | 37 YR | Required Intervention | ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM| MODEL #: SC-8216-70, SERIAL #: (B)(4) |