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	Fever (1858); Chills (2191); Dysuria (2684)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the intracept procedure was completed, the patient experienced a temperature of 99.5 degrees, symptoms of shivering and feeling cold, and pain during urination.The physician prescribed antibiotics for the patient's symptoms.The physician assessed the patient's symptoms as not being related to the device or procedure; however, the root cause of the patient's symptoms was unknown.The patient's symptoms resolved the next day and it was noted that there were no device issues during the intracept procedure.All devices used during the procedure were discarded by the medical facility and will not be returned for device analysis.
Additional Manufacturer Narrative
The device was not returned for analysis and the event of the patient experiencing a temperature of 99.5 degrees, symptoms of shivering and feeling cold, and pain during urination was not able to be confirmed.A review of the device history record (dhr) confirmed that the device met specifications prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A risk review was completed and confirmed that the event of medication required was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The device was not returned for analysis and the complaint as reported could not be confirmed.Record review revealed no additional information related to the complaint.Therefore, since the cause of the patients symptoms is unknown and the physician assessed that the patients symptoms as not being related to the device or procedure, this investigation is unable to determine a probable cause for the complaint.The conclusion code was determined to be cause not established.
Event or Problem Description
It was reported that after the intercept procedure was completed, the patient experienced a temperature of 99.5 degrees, symptoms of shivering and feeling cold, and pain during urination.The physician prescribed antibiotics for the patient's symptoms.The physician assessed the patient's symptoms as not being related to the device or procedure, however, the root cause of the patient's symptoms was unknown.The patient's symptoms resolved the next day and it was noted that there were no device issues during the intercept procedure.All devices used during the procedure were discarded by the medical facility and will not be returned for device analysis.

• 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: 24473947
• Report Number: 3006630150-2026-01157
• Device Sequence Number: 10278127
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2026

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 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 38251849
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 07/22/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/27/2026; 08/18/2026
• Date Device Manufactured: 09/25/2025
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 183 LB
• Patient Race: White