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

Model Number	RLV 0015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoxia (1918); Tachycardia (2095)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced shortness of breath, hypoxia, and slight tachycardia, leading to hospital admission.The patients medical history is significant for congestive heart failure, atrial fibrillation, chronic obstructive pulmonary disease, and obstructive sleep apnea.Laboratory testing was positive for respiratory syncytial virus (rsv).The patient was treated with duoneb, solu-medrol, and furosemide, and underwent electrocardiogram and laboratory evaluations.The patient remained hospitalized for two nights and was stabilized with diuretic therapy before being discharged.The event is reported to have resolved.The reported event occurred approximately four months after the intracept bvn (basivertebral nerve) ablation was performed.The reported event was assessed as not being related to the device or procedure.

• Brand Name: Intracept RF Probe
• 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; 7201 metro blvd ste 300; edina MN
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 25292741
• Report Number: 3006630150-2026-03509
• Device Sequence Number: 18521095
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)270328(10)37165704
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2026

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: Other
• Device Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 37165704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 07/14/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/23/2026; 07/28/2026
• Date Device Manufactured: 03/28/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 114 LB