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

Model Number	SC-8416-50
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the leads had high impedances.The patient needed an mri; therefore, the spinal cord stimulator system was explanted.
Additional Manufacturer Narrative
Sc-8416-50; (b)(6).The returned lead on this report was analyzed and the complaint of high impedances has been confirmed.It appears that excessive tensile force was exerted onto the lead and resulted in electrode dislodgement, paddle lead damage, and the reported high impedances.Therefore, the probable cause selected is cause traced to component failure.
Event or Problem Description
It was reported that the leads had high impedances.The patient needed an mri; therefore, the spinal cord stimulator system was explanted.
Event or Problem Description
It was reported that the leads had high impedances.The patient needed an mri; therefore, the spinal cord stimulator system was explanted.
Additional Manufacturer Narrative
This report is being submitted to correct the unique identifier (udi) # field (d4) in section d, suspect medical device.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21704047
• Report Number: 3006630150-2025-01943
• Device Sequence Number: 10130985
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 08/16/2019
• Device Model Number: SC-8416-50
• Device Catalogue Number: SC-8416-50
• Device Lot Number: 21014262
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 05/19/2026
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 08/18/2025; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2017
• 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: 42 YR
• Patient Sex: Female