FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 22333687
·
Received June 25, 2025
Report
- Report Number
- 3006630150-2025-04860
- Event Type
- Injury
- Date Received
- June 25, 2025
- Date of Event
- December 1, 2024
- Report Date
- June 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3 DATE OF EVENT: DATE APPROXIMATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR? 3-4 UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7075966, UDI: (B)(4). BRAND NAME: LINEAR? 3-4 UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7072603, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS LACKING PAIN RELIEF FROM HER SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1792773 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 540400 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Required Intervention |