MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION ARTISAN? MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-8416-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Paralysis (1997)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a spinal cord stimulation (scs) implant procedure, the patient experienced postoperative lower extremity paralysis.The patient had magnetic resonance imaging (mri) performed that showed bleeding and the patient underwent emergency surgery to evacuate a hematoma associated with the scs placement.The event was related to an unknown blood disorder.It was noted that the patient was currently in stable condition.
Event or Problem Description
It was reported that following a spinal cord stimulation (scs) implant procedure, the patient experienced postoperative lower extremity paralysis.The patient had magnetic resonance imaging (mri) performed that showed bleeding and the patient underwent emergency surgery to evacuate a hematoma associated with the scs placement.The event was related to an unknown blood disorder.It was noted that the patient was currently in stable condition.
Additional Manufacturer Narrative
A review of the manufacturing documentation for these device revealed that no anomalies or deviations related to the event occurred during manufacturing.The device remains implanted in the patient.As such, physical analysis has not been conducted in our laboratory.A product labeling review identified that the devices were used per the instructions for use (ifu) product label.The ifu states that possible surgical procedural risks include temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.Labelling review found that the reported event of paralysis and hematoma are a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.

• Brand Name: ARTISAN? MRI
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24783580
• Report Number: 3006630150-2026-02059
• Device Sequence Number: 6065381
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: (01)08714729951131(17)271029(10)7078348
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 7078348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female