FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? PRIME 16
MDR report key: 24658244
·
Received March 22, 2026
Report
- Report Number
- 3006630150-2026-01694
- Event Type
- Injury
- Date Received
- March 22, 2026
- Date of Event
- February 25, 2026
- Report Date
- May 29, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7074177 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM UNIQUE IDENTIFIER: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER : (B)(6). BATCH/LOT NUMBER: 7072173 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI): (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO INADEQUATE PAIN RELIEF. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65256 | WAVEWRITER ALPHA? PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 212156 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |