FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA PRIME 16
MDR report key: 21372875
·
Received February 13, 2025
Report
- Report Number
- 3006630150-2025-00678
- Event Type
- Injury
- Date Received
- February 13, 2025
- Date of Event
- January 2, 2025
- Report Date
- February 13, 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
- IN, 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: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7152391/7151888.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED, AND THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97838 | WAVEWRITER ALPHA PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 230383 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |