MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS, INC. INTRACEPT; PROBE, RADIOFREQUENCY LESION

Model Number	RLV 0045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced bradycardia while the physician was accessing the vertebral body.The patient was sedated using general anesthesia and no ablation was performed.As a result, the procedure was aborted.Medical intervention was performed for the patients bradycardia, however, no further information has been obtained despite good faith efforts.The patient is doing well postoperatively.
Event or Problem Description
It was reported that the patient experienced bradycardia while the physician was accessing the vertebral body.The patient was sedated using general anesthesia and no ablation was performed.As a result, the procedure was aborted.Medical intervention was performed for the patient's bradycardia, however, no further information has been obtained despite good faith efforts.The patient is doing well postoperatively.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.

• Brand Name: INTRACEPT
• 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: 21769810
• Report Number: 3006630150-2025-02125
• Device Sequence Number: 9658486
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)260923(10)818777
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222281
• 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 Expiration Date: 09/23/2026
• Device Model Number: RLV 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 818777
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 09/23/2024
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown