FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? 16
MDR report key: 22465366
·
Received July 9, 2025
Report
- Report Number
- 3006630150-2025-05329
- Event Type
- Injury
- Date Received
- July 9, 2025
- Date of Event
- March 17, 2025
- Report Date
- July 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF WEEKS FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7113705 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7114012 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 978707 | WAVEWRITER ALPHA? 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 556321 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |