ARTISAN
Report
- Report Number
- 3006630150-2022-06888
- Event Type
- Injury
- Date Received
- December 8, 2022
- Date of Event
- November 7, 2022
- Report Date
- January 20, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729779919
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7072133.
DEVICE ANALYSIS WAS NOT PERFORMED ON THE EXPLANTED PADDLE LEADS AS THEY WERE NOT RETURNED AND WERE RETAINED BY THE MEDICAL FACILITY. HOWEVER, IMAGING WAS TAKEN IN THE FIELD OF THE EXPLANTED PADDLE LEADS. THEREFORE, ENGINEERS WERE ABLE TO CONFIRM THAT THE PADDLE LEADS WERE CUT/DAMAGED. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) AFFIRMED THAT LEAD MIGRATION LIKELY RESULTING IN INADEQUATE STIMULATION IS A KNOWN INHERENT RISK WITH THE USE OF SPINAL CORD STIMULATION (SCS). BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8216700; MODEL: SC-8216-70; SERIAL: (B)(6); BATCH: 7072133.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE THERAPY AND X-RAYS CONFIRMED THE PADDLE LEADS HAD MIGRATED DOWNWARDS. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION BOTH LEADS. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC PLASMA BLADE TO MAKE AN INCISION IN THE PATIENTS NECK IN ORDER TO ACCESS THE PADDLE LEADS. A COMMUNICATION ERROR MESSAGE THEN APPEARED ON THE REMOTE CONTROL DURING AN ATTEMPT TO CHECK THE LEADS IMPEDANCES INTRAOPERATIVELY. THERE WAS VISIBLE DAMAGE TO SEVERAL CONTACTS ON BOTH PADDLE LEADS WHERE THE CONTACTS APPEARED TO BE LOOSE FROM EACH PADDLE. THEREFORE, BOTH PADDLE LEADS WERE REPLACED INSTEAD OF REPOSITIONED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE THERAPY AND X-RAYS CONFIRMED THE PADDLE LEADS HAD MIGRATED DOWNWARDS. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION BOTH LEADS. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC PLASMA BLADE TO MAKE AN INCISION IN THE PATIENTS NECK IN ORDER TO ACCESS THE PADDLE LEADS. A COMMUNICATION ERROR MESSAGE THEN APPEARED ON THE REMOTE CONTROL DURING AN ATTEMPT TO CHECK THE LEADS IMPEDANCES INTRAOPERATIVELY. THERE WAS VISIBLE DAMAGE TO SEVERAL CONTACTS ON BOTH PADDLE LEADS WHERE THE CONTACTS APPEARED TO BE LOOSE FROM EACH PADDLE. THEREFORE, BOTH PADDLE LEADS WERE REPLACED INSTEAD OF REPOSITIONED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2842991 | ARTISAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-70 | 7072020 | 08714729779919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |