FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 14649264
·
Received June 9, 2022
Report
- Report Number
- 3006630150-2022-02780
- Event Type
- Injury
- Date Received
- June 9, 2022
- Date of Event
- October 7, 2021
- Report Date
- June 9, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED MIDDLE OF (B)(6) 2021. EXPLANT DATE: MIDDLE OF (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7091852/7091939.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13158 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1216 | 512171 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |