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 Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients lead had migrated.Migration was thought to be caused by the patient excessively rotating her neck.The patient underwent a lead replacement procedure wherein a paddle lead was implanted.The patient was doing well postoperatively, and the explanted leads were not returned.
Event or Problem Description
It was reported that patient had only partial relief and stimulation had no effect on right side.It was noted that the lead migrated and was thought to be caused by the patient excessively rotating her neck.The patient underwent a lead replacement procedure wherein a paddle lead was implanted.The patient was doing well postoperatively, and the explanted leads were not returned.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device 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: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.
Event or Problem Description
It was reported that patient had only partial relief and stimulation had no effect on right side.It was noted that the lead migrated and was thought to be caused by the patient excessively rotating her neck.The patient underwent a lead replacement procedure wherein a paddle lead was implanted.The patient was doing well postoperatively, and the explanted leads were not returned.

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20549155
• Report Number: 3006630150-2024-07375
• Device Sequence Number: 15345794
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: (01)08714729951131(17)221006(10)7071104(21)7071104
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/29/2026

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 Expiration Date: 10/06/2022
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 7071104
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 04/12/2026; 05/08/2026
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 04/23/2026; 05/31/2026
• Date Device Manufactured: 10/06/2020
• 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: 53 YR
• Patient Sex: Female