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	Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred a couple days after the procedure date.
Event or Problem Description
It was reported that the patient was experiencing migraines and pain after the intracept procedure.Patient stated that he is a hard laborer and started to lift more at work.Shortly after that, the patient experienced new back pain and headaches began at night.The patient noted that he only feels pain when he moves, not when he is lying down.The patient was referred to his primary care physician (pcp) for elevated blood pressure and later admitted himself to the emergency room (er) a few days later.The patient was given prescription medications but could not remember what they were for.The patient was kept overnight at the er and was released the next day.Several tests were performed including a magnetic resonance imaging (mri) with contrast.All tests came back negative.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred a couple days after the procedure date.Correction to initial emdr in block d4.
Event or Problem Description
It was reported that the patient was experiencing migraines and pain after the intracept procedure.Patient stated that he is a hard laborer and started to lift more at work.Shortly after that, the patient experienced new back pain and headaches began at night.The patient noted that he only feels pain when he moves, not when he is lying down.The patient was referred to his primary care physician (pcp) for elevated blood pressure and later admitted himself to the emergency room (er) a few days later.The patient was given prescription medications but could not remember what they were for.The patient was kept overnight at the er and was released the next day.Several tests were performed including a magnetic resonance imaging (mri) with contrast.All tests came back negative.

• Brand Name: INTRACEPT RF PROBE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 94085
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd ste 300,; mn 55439; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21821151
• Report Number: 3006630150-2025-02370
• Device Sequence Number: 9482689
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)260718(10)108906629
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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 Expiration Date: 07/18/2026
• Device Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 108906629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 07/18/2024
• 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 Sex: Unknown