FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? PRIME
MDR report key: 25137305
·
Received May 11, 2026
Report
- Report Number
- 3006630150-2026-03044
- Event Type
- Injury
- Date Received
- May 11, 2026
- Date of Event
- April 16, 2026
- Report Date
- May 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985075
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7120175, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7120468, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) WAS NOT WORKING PROPERLY. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153805 | WAVEWRITER ALPHA? PRIME | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1432 | 210980 | 08714729985075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |