WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2026-00218
- Event Type
- Injury
- Date Received
- January 9, 2026
- Date of Event
- December 16, 2025
- Report Date
- April 1, 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: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9218150. MODEL: SC-9218-15. SERIAL: (B)(6). BATCH: 7082008. UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS. UPN: M365SC9218150. MODEL: SC-9218-15. SERIAL: (B)(6). BATCH: 7080159. UDI: (B)(4).
INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. LABELING REVIEW: A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES: ''POSSIBLE SURGICAL PROCEDURAL RISKS ARE: TEMPORARY PAIN AT THE IMPLANT SITE, INFECTION, CEREBROSPINAL FLUID (CSF) LEAKAGE AND, ALTHOUGH RARE, EPIDURAL HEMORRHAGE, SEROMA, HEMATOMA AND PARALYSIS'' AND "PERSISTENT PAIN AT THE IPG OR LEAD SITE" ARE A KNOWN RISKS WITH THE USE OF SPINAL CORD STIMULATION (SCS). INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7082008, UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7080159, UDI: (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN/DISCOMFORT AT THE IMPLANT SITE BELIEVED TO BE AN INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. ADDITIONAL INFORMATION STATED THAT THE EXPLANTED DEVICE WAS DISPOSED BY THE FACILITY. THERE WAS NO EXPECTATION THAT THE INFECTION WAS RELATED TO THE DEVICE. THE PATIENT WAS ON ANTIBIOTICS PRIOR TO REMOVAL AND AFTER.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN/DISCOMFORT AT THE IMPLANT SITE BELIEVED TO BE AN INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. ADDITIONAL INFORMATION STATED THAT THE EXPLANTED DEVICE WAS DISPOSED BY THE FACILITY. THERE WAS NO EXPECTATION THAT THE INFECTION WAS RELATED TO THE DEVICE. THE PATIENT WAS ON ANTIBIOTICS PRIOR TO REMOVAL AND AFTER.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN/DISCOMFORT AT THE IMPLANT SITE BELIEVED TO BE AN INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464508 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 794553 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |