FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? 16
MDR report key: 23605164
·
Received November 20, 2025
Report
- Report Number
- 3006630150-2025-10587
- Event Type
- Injury
- Date Received
- November 20, 2025
- Date of Event
- June 19, 2025
- Report Date
- November 20, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6) BATCH: 7082573 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7082551. UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PARESTHESIA ON THE LEFT OCCIPITAL REGION WITH NUMBNESS AND TINGLING. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE PROGRAM OPTIMIZATION. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WILL NOT BE RETURN DUE TO FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294504 | WAVEWRITER ALPHA? 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 787452 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention |