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

Model Number	SC-8416-70
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date unknown, event occurred in february 2024.Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri upn: m365sc12320 model: sc-1232 serial: (b)(6) batch: 513973.
Event or Problem Description
It was reported that following a non-device related procedure, the patient experienced inadequate stimulation.Upon interrogation, it was found that patient had high impedances on the proximal four contacts.The patient underwent implantable pulse generator (ipg) and spinal cord stimulation (scs) lead replacement procedure and was doing well postoperatively.The explanted devices were kept by the facility and will not be returned.

• Brand Name: ARTISAN MRI
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 20360733
• Report Number: 3006630150-2024-06594
• Device Sequence Number: 7284548
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: 08714729951131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 11/14/2021
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 1109902
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/03/2024
• 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: 45 YR
• Patient Sex: Female