FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 1400486
·
Received June 11, 2009
Report
- Report Number
- 2029203-2009-01112
- Event Type
- Injury
- Date Received
- June 11, 2009
- Report Date
- July 15, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PATIENT WEIGHT NOT AVAILABLE. DATE OF EVENT IS 2007. EXACT DATE NOT AVAILABLE. ADDITIONAL SUSPECT DEVICE COMPONENTS INVOVLED IN THE EVENT: MODEL: SC-8116-70 DESCRIPTION: ARTISAN 2X8 PADDLE LEAD MODEL: SC-3108-25 DESCRIPTION: LEAD EXTENSION, 25 CM (PHASE I) MODEL: SC-3108-25 DESCRIPTION: LEAD EXTENSION, 25 CM (PHASE I) A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURED DURING MANUFACTURING. THIS IS A FINAL REPORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT DUE TO BELIEVING THE DEVICE "WAS NOT WORKING." NO FURTHER INFOMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |