FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? PRIME 16
MDR report key: 23472999
·
Received November 4, 2025
Report
- Report Number
- 3006630150-2025-09998
- Event Type
- Injury
- Date Received
- November 4, 2025
- Date of Event
- October 19, 2025
- Report Date
- November 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7072216/7072234; UDI: (B)(4); UDI: (B)(4).
Additional Manufacturer Narrative · 0
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NON-TARGET STIMULATION UNDESIRED SENSATIONS. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NON-TARGET STIMULATION UNDESIRED SENSATIONS. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2638046 | WAVEWRITER ALPHA? PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 222431 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |