FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER?
MDR report key: 21773738
·
Received April 4, 2025
Report
- Report Number
- 3006630150-2025-02144
- Event Type
- Injury
- Date Received
- April 4, 2025
- Date of Event
- October 26, 2020
- Report Date
- April 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF YEARS AFTER DATE OF IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500, MODEL: SC-8336-50 , SERIAL: (B)(6), BATCH: 7030421, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE WAS NO LONGER PROVIDING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2324467 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 342815 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |