FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 8297067
·
Received February 1, 2019
Report
- Report Number
- 3006630150-2019-00331
- Event Type
- Injury
- Date Received
- February 1, 2019
- Date of Event
- December 28, 2018
- Report Date
- February 1, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7023684, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90379 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 21263545 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |