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	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a basivertebral nerve ablation at multiple levels.The physician completed the case successfully.However, after the procedure, the patient was admitted to the intensive care unit (icu) for a retroperitoneal bleed.The physician ordered a computed tomography (ct) scan with an angiogram, which showed a lumbar artery aneurysm.The patient received an embolization in radiology.All devices were discarded by the medical facility and will not be returned, as there were no reported device issues.The patient is doing well postoperatively and has no complications.
Event or Problem Description
It was reported that the patient underwent a basivertebral nerve ablation at multiple levels.The physician completed the case successfully.However, after the procedure, the patient was admitted to the intensive care unit (icu) for a retroperitoneal bleed.The physician ordered a computed tomography (ct) scan with an angiogram, which showed a lumbar artery aneurysm.The patient received an embolization in radiology.All devices were discarded by the medical facility and will not be returned, as there were no reported device issues.The patient is doing well postoperatively and has no complications.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.

• 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: 21639167
• Report Number: 3006630150-2025-01634
• Device Sequence Number: 6828692
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 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: 02/21/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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; Hospitalization
• Patient Sex: Unknown