FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 25214638
·
Received May 19, 2026
Report
- Report Number
- 3006630150-2026-03267
- Event Type
- Injury
- Date Received
- May 19, 2026
- Date of Event
- April 24, 2026
- Report Date
- May 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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-8336-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7070354. MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9106 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 531361 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |