FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 21422562
·
Received February 20, 2025
Report
- Report Number
- 3006630150-2025-00895
- Event Type
- Injury
- Date Received
- February 20, 2025
- Date of Event
- January 28, 2025
- Report Date
- February 20, 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
- 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7043404.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTENSE PAIN IN THEIR BACK. ADDITIONALLY, THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS NOT PROVIDING PAIN RELIEF OR STIMULATION. AN INFECTION WAS ALSO MENTIONED. ALL DEVICE COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464559 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 350320 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |