FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 8853246
·
Received August 1, 2019
Report
- Report Number
- 3006630150-2019-03975
- Event Type
- Injury
- Date Received
- August 1, 2019
- Date of Event
- July 15, 2019
- Report Date
- August 1, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER:SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5142343/5142458, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATENT UNDERWENT EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646905 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 352280 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |