ARTISAN?
Report
- Report Number
- 3006630150-2025-04665
- Event Type
- Injury
- Date Received
- June 19, 2025
- Date of Event
- May 25, 2025
- Report Date
- December 19, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729779902
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D6B: EXPLANT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY SCS-IPG-PC, UPN M365SC14160, MODEL SC-1416, SERIAL-LOT (B)(6), BATCH 233764, UDI (B)(4).
BLOCK D6B: EXPLANT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY SCS-IPG-PC. UPN M365SC14160. MODEL SC-1416. SERIAL-LOT (B)(6). BATCH (B)(6). UDI (B)(4).
IT WAS REPORTED THAT TWO DAYS FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO MOVE THEIR LEGS AND WAS HOSPITALIZED. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE A HEMATOMA OR OTHER COMPLICATIONS FROM THE PROCEDURE CAUSING THE PATIENTS PARALYSIS SYMPTOMS. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED HOWEVER THE RESULTS ARE UNAVAILABLE. THE PATIENTS ENTIRE SCS SYSTEM WAS EXPLANTED. THE SURGEON DECOMPRESSED NECESSARY LEVELS OVER THE COURSE OF 2-3 SURGERIES PERFORMED AT TWO DIFFERENT FACILITIES. THE PATIENT IS AT AN INPATIENT REHABILITATION FACILITY, IS NON-AMBULATORY, AND IS WORKING WITH THERAPY TO REGAIN THE ABILITY TO WALK.
IT WAS REPORTED THAT TWO DAYS FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO MOVE THEIR LEGS AND WAS HOSPITALIZED. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE A HEMATOMA OR OTHER COMPLICATIONS FROM THE PROCEDURE CAUSING THE PATIENTS PARALYSIS SYMPTOMS. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED HOWEVER THE RESULTS ARE UNAVAILABLE. THE PATIENTS ENTIRE SCS SYSTEM WAS EXPLANTED. THE SURGEON DECOMPRESSED NECESSARY LEVELS OVER THE COURSE OF 2-3 SURGERIES PERFORMED AT TWO DIFFERENT FACILITIES. THE PATIENT IS AT AN INPATIENT REHABILITATION FACILITY, IS NON-AMBULATORY, AND IS WORKING WITH THERAPY TO REGAIN THE ABILITY TO WALK. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746882 | ARTISAN? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-8216-50 | 7079232 | 08714729779902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Hospitalization| R |