FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 21958766
·
Received May 5, 2025
Report
- Report Number
- 3006630150-2025-03046
- Event Type
- Injury
- Date Received
- May 5, 2025
- Date of Event
- May 23, 2024
- Report Date
- May 5, 2025
- 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
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN MAY 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7142731, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7142482, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPLANTED. THE EXPLANTED DEVICE WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1873111 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 753603 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |