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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Pain (1994); Fluid Discharge (2686)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-1216 serial number: (b)(6).Batch/lot number: 813577 model/catalog description: wavewriter alpha 16 ipg kit unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318 batch/lot number: 38724760 model/catalog description: clik x anchor sterile kit unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient experienced lead migration following a fall, which was confirmed through imaging studies.Upon evaluation, the physician observed that the midline spinal incision appeared suspicious, though no external drainage was present.The patient was taken to the operating room for further assessment.During surgical exploration of the spinal incision, suspicious fluid was encountered within the midline incision cavity.Both superficial and deep cultures were obtained for analysis.Subsequently, the patient underwent a spinal cord stimulation (scs) explant procedure.Postoperatively, the patient was admitted for inpatient care and will be initiated on antibiotic therapy.Explants discarded per facility biohazard protocol.

• 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: 25740370
• Report Number: 3006630150-2026-04753
• Device Sequence Number: 21446019
• Product Code: LGW
• UDI-Device Identifier: 08714729951124
• UDI-Public: (01)08714729951124(17)280210(10)7081028
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,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-8416-50
• Device Catalogue Number: SC-8416-50
• Device Lot Number: 7081028
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 06/18/2026; Not provided; 09/02/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 07/13/2026; 09/04/2026; 09/25/2026
• Date Device Manufactured: 02/10/2026
• 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: 61 YR
• Patient Sex: Male