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

Model Number	RLV 0055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, the patient vomited after the physician accessed the first pedicle.The patient had to be flipped supine to re-establish airway and the physician cancelled the procedure.The patient was sedated and there were no reported device issues.The patient was doing well postoperatively.Approximately two weeks after the cancelled procedure, the patient underwent another intracept procedure and it was completed successfully.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.
Event or Problem Description
It was reported that during an intracept procedure, the patient vomited after the physician accessed the first pedicle.The patient had to be flipped supine to re-establish airway and the physician cancelled the procedure.The patient was sedated and there were no reported device issues.The patient was doing well postoperatively.Approximately two weeks after the cancelled procedure, the patient underwent another intracept procedure and it was completed successfully.

• 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: 21633236
• Report Number: 3006630150-2025-01603
• Device Sequence Number: 9511027
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)260926(10)818775
• 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): 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: 09/26/2026
• Device Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 818775
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 09/26/2024
• 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 Sex: Unknown