FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER?
MDR report key: 22006831
·
Received May 12, 2025
Report
- Report Number
- 3006630150-2025-03283
- Event Type
- Injury
- Date Received
- May 12, 2025
- Date of Event
- January 1, 2024
- Report Date
- May 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2024. D6B: EXPLANT DATE: 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 7071254. UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2300493 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 372084 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |