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	Insufficient Information (4580)
Date of Event	02/21/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient had an intracept procedure and the procedure was completed successfully.However, the patient had an issue with the anesthesia.The patient was transported to the emergency room (er) post-procedure.The patient passed away after some anesthesia challenges post-procedure.The physician acknowledged that the patients death was not a procedure or device-related complication.No devices will be returned.
Event or Problem Description
It was reported that the patient had an intracept procedure and the procedure was completed successfully.However, the patient had an issue with the anesthesia.The patient was transported to the emergency room (er) post-procedure.The patient passed away after some anesthesia challenges post-procedure.The physician acknowledged that the patients death was not a procedure or device-related complication.No devices will be returned.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.
Event or Problem Description
It was reported that the patient had an intracept procedure and the procedure was completed successfully.However, the patient had an issue with the anesthesia.The patient was transported to the emergency room (er) post-procedure.The patient passed away after some anesthesia challenges post-procedure.The physician acknowledged that the patient's death was not a procedure or device-related complication.

• 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: 21656127
• Report Number: 3006630150-2025-01664
• Device Sequence Number: 12644073
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)260809(10)108652653
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/11/2025

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: 08/09/2026
• Device Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 108652653
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 06/17/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/24/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: Death
• Patient Age: 75 YR
• Patient Sex: Female