FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 25256633
·
Received May 22, 2026
Report
- Report Number
- 3006630150-2026-03386
- Event Type
- Injury
- Date Received
- May 22, 2026
- Date of Event
- May 13, 2021
- Report Date
- May 22, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK D6B: EXPLANT DATE: 4 YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072051. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506385 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 510507 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |