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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Numbness (2415); Movement Disorder (4412); Thrombosis/Thrombus (4440)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced numbness in bilateral legs and difficulty with movement of right leg overnight after the scs implant procedure.A computerized tomography (ct) scan revealed an epidural hematoma above the lead site.The physician assessed that a surgical tool that was used during the implant procedure may have made contact with a vein causing the hematoma.Therefore, the patient underwent a surgical procedure to evacuate the hematoma and remove the blood clot.No devices were removed and all impedances were normal.The patient was stable postoperatively.There was no further course of action planned.

• 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: 18992622
• Report Number: 3006630150-2024-01857
• Device Sequence Number: 20717735
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: 08714729951131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/18/2024
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 7070885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male