FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 9397673
·
Received December 2, 2019
Report
- Report Number
- 3006630150-2019-06989
- Event Type
- Injury
- Date Received
- December 2, 2019
- Date of Event
- July 29, 2019
- Report Date
- December 2, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5111802/5112580; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1192568 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 346921 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |