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 Codes	Fall (1848); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Presyncope (4410); Limb Fracture (4518)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an intercept procedure, the patient experienced a superficial forming hematoma that responded to pressure.The patient had skin incisions that bled quite a bit, but the patient was discharged stable.Upon returning home, the patient became lightheaded while walking to the front door and fell to his knee.The patient was hypotensive when emergency medical services (ems) arrived.The patient was taken to the emergency department (ed) and was diagnosed with a femoral fracture and had a low blood count.A ct (computed tomography) abdomen scan revealed a large left retroperitoneal hematoma without active bleeding.The patient was treated with a transfusion and a serial ct scan showed a resolving hematoma.The patient was discharged stable.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced a superficial forming hematoma that responded to pressure.The patient had skin incisions that bled quite a bit, but the patient was discharged stable.Upon returning home, the patient became lightheaded while walking to the front door and fell to his knee.The patient was hypotensive when emergency medical services (ems) arrived.The patient was taken to the emergency department (ed) and was diagnosed with a femoral fracture and had a low blood count.A ct (computed tomography) abdomen scan revealed a large left retroperitoneal hematoma without active bleeding.The patient was treated with a transfusion and a serial ct scan showed a resolving hematoma.The patient was discharged stable.
Event or Problem Description
It was reported that after an intracept procedure, the patient experienced a superficial forming hematoma that responded to pressure.The patient had skin incisions that bled quite a bit, but the patient was discharged stable.Upon returning home, the patient became lightheaded while walking to the front door and fell to his knee.The patient was hypotensive when emergency medical services (ems) arrived.The patient was taken to the emergency department (ed) and was diagnosed with a femoral fracture and had a low blood count.A ct (computed tomography) abdomen scan revealed a large left retroperitoneal hematoma without active bleeding.The patient was treated with a transfusion and a serial ct scan showed a resolving hematoma.The patient was discharged stable.
Additional Manufacturer Narrative
The device was not returned for analysis, therefore, a technical analysis could not be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use, ifu/product label.However, the ifu state: "pedicle or vertebral body fracture", "nerve injury including puncture of the spinal cord or nerve roots potentially resulting in radiculopathy, paresis or paralysis", and "improper entry and placement of the devices may result in patient injury and/or sub-optimal clinical treatment effects" are adverse events potentially associated with use the intracept intraosseous nerve ablation system.The reported event of the patient experiencing a hematoma could not be confirmed, as the device was not returned for analysis.However, a labelling review found that the reported event is a known risk associated with the use of the intracept intraosseous nerve ablation system.Therefore, this event is a known inherent risk with use of the intracept intraosseous nerve ablation system.

• 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): Boston Scientific Corporation; 7201 metro blvd ste 300; edina MN
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 21978657
• Report Number: 3006630150-2025-03138
• Device Sequence Number: 9274428
• Product Code: GXI
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 08/05/2026

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: 35338734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 04/30/2026; 07/08/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/10/2025; 05/28/2026; 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male