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 Code	Vertebral Fracture (4520)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the basivertebral nerve (bvn) radiofrequency ablation (rfa) procedure transverse process, fracture at the vertebral levels treated were noted.Based on the physicians assessment, the procedure did contribute to the adverse event.The procedure was completed as planned without any device malfunction and there was not any medical intervention.Post operatively, the patient is stable and currently, there is no next course of action.The device will not return for analysis as it was discarded by the medical facility.

• 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: 50900349
• Report Number: 3006630150-2026-07099
• Device Sequence Number: 12268646
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)280614(10)39756506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Device Model Number: RLV 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 39756506
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/15/2026
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Unknown