FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 1400641
·
Received June 11, 2009
Report
- Report Number
- 2029203-2009-00623
- Event Type
- Injury
- Date Received
- June 11, 2009
- Date of Event
- February 15, 2006
- Report Date
- February 17, 2006
- 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. ADDITIONAL SUSPECT DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8116-70, SC-2138-70, SC-2138-70, SC-2138-70 DESCRIPTION: SCS PADDLE LEAD (70 CM), PHASE III LINEAR LEAD (70 CM) - 3 SETS PRODUCT ANALYSIS SHOWED THAT ALL DEVICES HAD NORMAL CHARACTERISTICS. THIS IS A FINAL REPORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, THE PHYSICIAN DISCOVERED SCAR TISSUE. THE PHYSICIAN WAS UNABLE TO CONTINUE WITH THE PROCEDURE AND EXPLANTED THE PATIENT'S SYSTEM. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE EXPLANT.
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 | 45 YR | Required Intervention |