FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2874152
·
Received December 14, 2012
Report
- Report Number
- 3006630150-2012-02377
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 1, 2012
- 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
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2158-50E, SERIAL #: (B)(4), DESCRIPTION: TRIAL LINEAR LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD A CEREBROSPINAL FLUID LEAKAGE DURING A TRIAL PROCEDURE. THE LEADS WERE PULLED OUT AND THE PATIENT WAS GIVEN FIBRIN GLUE TO SEAL THE EPIDURAL SPACE. THE EVENT WAS PROCEDURE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2158-50E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |