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

Model Number	SC-8216-50
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Memory Loss/Impairment (1958); Paralysis (1997)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that she had several episodes of semi-paralysis, spots on her brain, and recent memory loss.The patient has not used the spinal cord stimulation (scs) for over a year due to inadequate stimulation, however, imaging will be taken.

• Brand Name: ARTISAN?
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25833735
• Report Number: 3006630150-2026-04969
• Device Sequence Number: 10411863
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: (01)08714729779902(17)161201(10)17479470
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2016
• Device Model Number: SC-8216-50
• Device Catalogue Number: SC-8216-50
• Device Lot Number: 17479470
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 12/02/2014
• 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; Other
• Patient Age: 63 YR
• Patient Sex: Female