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 Codes	Muscle Weakness/Atrophy (1967); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an intracept procedure where the l5 lumbar vertebrae and s1 sacral vertebrae were accessed, and the targets were reached successfully.While accessing l5, the provider noted he was in the pedicle and based on imaging, it was possible he was accessing the inferior portion of the pedicle.After the procedure, the patient experienced minor weakness in their right leg.The patient elected to go to the hospital for observation due to lack of support at home.The patient was released within twenty-four hours.It was noted by the provider that the patient has some psychiatric issues, but the patient has recovered.The physician assessed that the patients nerve may have been aggravated during the procedure.The patient was in good health and did not have any further issues.The devices were discarded by the medical facility.
Additional Manufacturer Narrative
This report is being submitted to correct the describe event or problem field (b5) in section b, adverse event/product problem, manufacturer state (d3) in section d, suspect medical device, and device code (h6) in section h, device manufacturers only.
Event or Problem Description
It was reported that the patient underwent an intracept procedure where the l5 lumbar vertebrae and s1 sacral vertebrae were accessed, and the targets were reached successfully.While accessing l5, the provider noted he was in the pedicle and based on imaging, it was possible he was accessing the inferior portion of the pedicle.After the procedure, the patient experienced minor weakness in their right leg.The patient elected to go to the hospital for observation due to lack of support at home.The patient was released within twenty-four hours.The patient was in good health and did not have any further issues.The devices were discarded by the medical facility.

• 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 ; 7632920920
• MDR Report Key: 22868838
• Report Number: 3006630150-2025-06738
• Device Sequence Number: 9285582
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270204(10)36509579
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/19/2025

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 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 36509579
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 02/03/2025
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Black Or African American