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	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred over the last few years from the date manufacturer became aware of the event.Additional suspect medical device components involved in the event: model number/catalog number: sc-4316.Batch/lot number: 16920411.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient spinal cord stimulation (scs) leads were fractured due to patient fell several times.The patient underwent lead replacement procedure and was doing well post operatively.The explanted device components were not returned.

• 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 ; * 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25156599
• Report Number: 3006630150-2026-03103
• Device Sequence Number: 9325229
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: (01)08714729779902(17)160219(10)16739512
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted 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): 06/26/2026

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: 02/19/2016
• Device Model Number: SC-8216-50
• Device Catalogue Number: SC-8216-50
• Device Lot Number: 16739512
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 02/19/2014
• 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
• Patient Age: 33 YR
• Patient Sex: Male