ARTISAN
Report
- Report Number
- 3006630150-2023-05524
- Event Type
- Injury
- Date Received
- September 13, 2023
- Date of Event
- August 13, 2023
- Report Date
- December 11, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729779902
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(6), LOT: 211861.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). LOT: 211861.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC; UPN: M365SC14320; MODEL: SC-1432; SERIAL: (B)(6); LOT: 211861.
IT WAS REPORTED THAT THE PATIENT HAD BEEN SENT HOME AFTER A SPINAL CORD STIMULATION IMPLANT PROCEDURE WITH INSTRUCTIONS TO NOT TAKE HIS BLOOD THINNERS FOR FIVE DAYS, HOWEVER, THE PATIENT TOOK THE BLOOD THINNERS THREE DAYS AFTER THE PROCEDURE. THE PATIENT THEN FELL AND LOST FEELING IN HIS LEGS. THE PATIENT WENT TO THE EMERGENCY ROOM, WAS THEN FLOWN TO A FACILITY WHERE THE PADDLE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED, AND THEN MOVED TO THE INTENSIVE CARE UNIT. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE PATIENT HAD BEEN SENT HOME AFTER A SPINAL CORD STIMULATION IMPLANT PROCEDURE WITH INSTRUCTIONS TO NOT TAKE HIS BLOOD THINNERS FOR FIVE DAYS, HOWEVER, THE PATIENT TOOK THE BLOOD THINNERS THREE DAYS AFTER THE PROCEDURE. THE PATIENT THEN FELL AND LOST FEELING IN HIS LEGS. THE PATIENT WENT TO THE EMERGENCY ROOM, WAS THEN FLOWN TO A FACILITY WHERE THE PADDLE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED, AND THEN MOVED TO THE INTENSIVE CARE UNIT. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND ADMITTED TO A LONGER-TERM PHYSICAL THERAPY FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT SUFFERS FROM PARALYSIS.
IT WAS REPORTED THAT THE PATIENT HAD BEEN SENT HOME AFTER A SPINAL CORD STIMULATION IMPLANT PROCEDURE WITH INSTRUCTIONS TO NOT TAKE HIS BLOOD THINNERS FOR FIVE DAYS, HOWEVER, THE PATIENT TOOK THE BLOOD THINNERS THREE DAYS AFTER THE PROCEDURE. THE PATIENT THEN FELL AND LOST FEELING IN HIS LEGS. THE PATIENT WENT TO THE EMERGENCY ROOM, WAS THEN FLOWN TO A FACILITY WHERE THE PADDLE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED, AND THEN MOVED TO THE INTENSIVE CARE UNIT. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND ADMITTED TO A LONGER TERM PHYSICAL THERAPY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83969 | ARTISAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | 7074498 | 08714729779902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Other| H| R |