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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-8216-70.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: artisan lead 70 cm.Unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the patient underwent an implant procedure to cover pain areas and it was noted in the neuromonitoring that the patient lost signal in the bilateral legs.Eventually, the patient regained motor senses back to normal and the procedure was completed without other complications.The patient was doing well postoperatively.
Event or Problem Description
It was reported that the patient underwent an implant procedure to cover pain areas and it was noted in the neuromonitoring that the patient lost signal in the bilateral legs.Eventually, the patient regained motor senses back to normal and the procedure was completed without other complications.The patient was doing well postoperatively.Additional information was received that the patient's symptoms were not device related.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-8216-70.Serial number: (b)(6).Batch/lot number: 7078114.Model/catalog description: artisan lead 70 cm.Unique identifier (udi): (b)(4).Investigation results: all explanted devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that all devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: all explanted devices were not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint and the conclusion code cause not established will be used.

• 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; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25122306
• Report Number: 3006630150-2026-02972
• Device Sequence Number: 8661563
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: (01)08714729779902(17)280209(10)7081017
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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-8216-50
• Device Catalogue Number: SC-8216-50
• Device Lot Number: 7081017
• Was Device Available for Evaluation?: No
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 07/08/2026; 08/28/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/25/2026
• Date Device Manufactured: 02/09/2026
• 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: 60 YR
• Patient Sex: Male