MAUDE Adverse Event Report: Relievant Medsystems, Inc. Intracept; Probe, Radiofrequency Lesion

Model Number	RLV 0065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Chest Pain (1776); Tachycardia (2095); Cough (4457)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury

• Brand Name: Intracept
• Common Device Name: Probe, Radiofrequency Lesion
• Manufacturer (Section D): Relievant Medsystems, Inc.; 1230 midas way suite 200; sunnyvale 94085
• Manufacturer (Section G): Boston Scientific Corporation; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50900356
• Report Number: 3006630150-2026-07100
• Device Sequence Number: 20340155
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)280712(10)85169983
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: RLV 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 85169983
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 07/13/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown