FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 25212204
·
Received May 19, 2026
Report
- Report Number
- 3006630150-2026-03260
- Event Type
- Injury
- Date Received
- May 19, 2026
- Date of Event
- March 18, 2026
- Report Date
- May 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- 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 COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7075667. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50. BATCH/LOT NUMBER: (B)(6). SERIAL NUMBER: 7072961. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER HOLDING A CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323205 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 532538 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |