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

Model Number	RLV 0055
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Movement Disorder (4412)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intracept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patients fracture could not be confirmed.
Event or Problem Description
It was reported that the intracept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patient's fracture could not be confirmed.Additional information was received that the patient will undergo a kyphoplasty.The fracture was identified at a follow-up visit postoperatively.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.
Event or Problem Description
It was reported that the intracept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patients fracture could not be confirmed.
Additional Manufacturer Narrative
Correction to supplemental emdr in describe event or problem field (b5) in section b, adverse event or product problem.
Event or Problem Description
It was reported that the intracept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patients fracture could not be confirmed.Additional information was received that the patient will undergo a kyphoplasty.The fracture was identified at a follow-up visit postoperatively.
Event or Problem Description
It was reported that the intercept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patient's fracture could not be confirmed.Additional information was received that the patient will undergo a kyphoplasty.The fracture was identified at a follow-up visit postoperatively.Additional information was received that the patient was treated with a kyphoplasty.Additional information was received that the patient was treated with a kyphoplasty.
Additional Manufacturer Narrative
Correction to supplemental emdr in describe event or problem field (b5) in section b, adverse event or product problem.
Additional Manufacturer Narrative
This report is being submitted to correct the model number and catalog number field (d4) in section d, suspect medical device.The lot number is unknown as no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that the intracept procedure did not provide effective pain relief for the patient.The patient experienced pain, difficulty walking, and a fracture after the procedure.Imaging was not provided and as a result, the patient's fracture could not be confirmed.Additional information was received that the patient will undergo a kyphoplasty.The fracture was identified at a follow-up visit postoperatively.Additional information was received that the patient was treated with a kyphoplasty.

• 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: 20896850
• Report Number: 3006630150-2024-08612
• Device Sequence Number: 5004100
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)260306(10)106538945
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/25/2025

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: 03/06/2026
• Device Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 106538945
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 06/17/2025; 09/03/2025; 10/01/2025; 10/31/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/08/2025; 07/09/2025; 10/01/2025; 10/31/2025; 11/25/2025
• Date Device Manufactured: 03/07/2024
• 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; Other
• Patient Age: 81 YR
• Patient Sex: Unknown