WAVEWRITER ALPHA? PRIME 16
Report
- Report Number
- 3006630150-2025-09239
- Event Type
- Injury
- Date Received
- October 17, 2025
- Date of Event
- September 25, 2022
- Report Date
- April 9, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A FEW YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.
INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN:M365SC8216500 MODEL:SC-8216-50 SERIAL:(B)(6). BATCH:7071667 UDI:(B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A BAD EXPERIENCE THAT THE PATIENT HAD WITH THE IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A BAD EXPERIENCE THAT THE PATIENT HAD WITH THE IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEAD WAS EXPLANTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A BAD EXPERIENCE THAT THE PATIENT HAD WITH THE IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1618572 | WAVEWRITER ALPHA? PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 210722 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |