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	Off-Label Use (1494)
Health Effect - Clinical Codes	Hematoma (1884); Numbness (2415); Paresthesia (4421)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a cervical implant procedure, the patient experienced numbness and tingling in the upper and lower extremities.The physician suspected hematoma.The patient was brought back into the operating room and underwent spinal cord stimulator (scs) explant procedure.All explanted device components will not be returned per facility policy.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-1232, serial number: (b)(6), batch/lot number: 822208, model/catalog description: wavewriter alpha 32 ipg kit, unique identifier (udi): (b)(4), model number/catalog number: sc-4316, batch/lot number: 38845778, model/catalog description: clik anchor, unique identifier (udi): (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25874099
• Report Number: 3006630150-2026-05082
• Device Sequence Number: 18157016
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: (01)08714729951131(17)270626(10)7077800
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 7077800
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 06/26/2025
• 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
• Patient Age: 59 YR
• Patient Sex: Male