PRECISION SPECTRA®
Report
- Report Number
- 3006630150-2016-01463
- Event Type
- Injury
- Date Received
- June 8, 2016
- Date of Event
- May 12, 2016
- Report Date
- May 12, 2016
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
ADDITIONAL INFORMATION WAS RECEIVED THAT EVERYTHING WAS EXPLANTED FROM THE PATIENT INCLUDING THE MISSING ELECTRODE AND 32 CONTACT LEAD. SC-8336-50/1071277 DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD RIPPED INSIDE THE PATIENT'S BODY AS CONFIRMED BY REP'S SUBMITTED IMAGES. THE VISUAL INSPECTION OF THE PADDLE LEAD REVEALED THAT SILICON WAS TORN AND ONE SECTION IS MISSING. IN ADDITION, THE CABLES NEAR THE PADDLE WERE PULLED AND EXPOSED. X-RAY INSPECTION FOUND THAT 19 OUT OF 32 ELECTRODES ARE MISSING FROM THE PADDLE.
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. AN IMAGING WAS TAKEN AND SHOWED SIGNS OF THE LEAD POSSIBLY BENDING AND THE CONTACTS HAD FALLEN OF. IT WAS DETERMINED THAT THE LEAD WAS RIPPED INTO SEVERAL PIECES AND WAS NO LONGER WORKING. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. AN IMAGING WAS TAKEN AND SHOWED SIGNS OF THE LEAD POSSIBLY BENDING AND THE CONTACTS HAD FALLEN OF. IT WAS DETERMINED THAT THE LEAD WAS RIPPED INTO SEVERAL PIECES AND WAS NO LONGER WORKING. THE LEAD WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360647 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8336-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |