SPECTRA WAVEWRITER?
Report
- Report Number
- 3006630150-2024-05385
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- June 11, 2024
- Report Date
- May 28, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7070616. UDI: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7070616.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATOR (SCS) WAS HURTING PATIENT'S BACK.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2179640 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 363846 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Required Intervention |