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 Code	Pain (1994)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced severe sciatic pain.The patient was treated with gabapentin.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced severe sciatic pain.The patient was treated with gabapentin.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced severe sciatic pain.The patient was treated with gabapentin.No further information has been obtained despite good faith efforts.Additional information was received that there was a possible pedicle breach, so gabapentin was used to treat the patient.
Additional Manufacturer Narrative
Correction to first supplemental emdr in blocks g3, h2, h11: block g3: bsc aware date: 10jun2025.Block h2: follow-up report type: additional information.Block h11: additional mfr narrative: blocks a1 and a3 were updated.
Additional Manufacturer Narrative
Correction to initial emdr in blocks b2 and d4.
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced severe sciatic pain.The patient was treated with gabapentin.No further information has been obtained despite good faith efforts.

• 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 Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22178897
• Report Number: 3006630150-2025-04274
• Device Sequence Number: 8841484
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/14/2025

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 Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 07/10/2025; 07/23/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/09/2025; 07/10/2025; 08/14/2025
• 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: Other
• Patient Sex: Male