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	Insufficient Information (4580)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, the patients vital signs dropped when the s1 sacral vertebrae was accessed through the pedicle.The j-stylet was advanced about halfway through the threads when the patients vital signs dropped.As a result, the event prompted the crash cart to be called into the room.Ablation was not attempted and the procedure was aborted.In addition, the boston scientific sales representative stated that the patient was on the floor.No products will be returned as they were discarded by the facility.
Event or Problem Description
It was reported that during an intracept procedure, the patient's vital signs dropped when the s1 sacral vertebrae was accessed through the pedicle.The j-stylet was advanced about halfway through the threads when the patients vital signs dropped.As a result, the event prompted the crash cart to be called into the room.Ablation was not attempted and the procedure was aborted.In addition, the boston scientific sales representative stated that the patient was on the floor.No products will be returned as they were discarded by the facility.Additional information was received that iv sedation was used during the procedure and the patient is doing well.The physician assessed the patients dropping vital signs as unrelated to the procedure.Additional information was received that iv sedation was used during the procedure and the patient is doing well.The physician assessed the patient's dropping vital signs as unrelated to the procedure.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale 94085
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 7201 metro blvd ste 300; edina MN
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22758767
• Report Number: 3006630150-2025-06310
• Device Sequence Number: 21182272
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)261212(10)35788400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/05/2025

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 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 35788400
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 12/12/2024
• 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: 65 YR
• Patient Sex: Male