WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2024-08492
- Event Type
- Injury
- Date Received
- December 6, 2024
- Date of Event
- November 9, 2024
- Report Date
- May 29, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FIVE DAYS PRIOR FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2318700. MODEL: SC-2318-70. SERIAL: (B)(6). BATCH: 5001303. UDI: (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD WOUND OVER THE IMPLANTABLE PULSE GENERATOR (IPG) SITE THAT WAS NOT HEALING FOLLOWING THE REVISION PROCEDURE (MFR. 3006630150-2024-07521). THE PATIENT WAS SENT FOR WOUND CARE AND WAS GIVEN ANTIBIOTICS.
IT WAS REPORTED THAT THE PATIENT HAD WOUND OVER THE IMPLANTABLE PULSE GENERATOR (IPG) SITE THAT WAS NOT HEALING FOLLOWING THE REVISION PROCEDURE (MFR. 3006630150-2024-07521). THE PATIENT WAS SENT FOR WOUND CARE AND WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL DEVICE COMPONENTS WERE EXPLANTED AND DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354129 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 761666 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |