MAUDE Adverse Event Report: Relievant Medsystems, Inc. Intracept; Probe, Radiofrequency Lesion

Model Number	RLV 0065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior the basivertebral nerve (bvn) radiofrequency ablation (rfa) procedure for vertebrogenic pain there was a problem with patient positioning that created an anesthesia concern, therefore the patient was flipped back onto the bed to ensure safety and stabilization.Once patient was stable, the physicians elected to continue the procedure.Physician began procedure at s1 level and gained access to vertebral body.Once the channel was created to intended target, the probe was opened from its box and placed in the channel to appropriate ablation zone.The physician elected for a 15 minute ablation and the ablation began.Physician began marking l5 incision point with a skin marker when the patient began moving.Anesthesia issues began to arise again and physician stopped marking to ensure patient was not moving.Six minutes after the ablation of s1 started, anesthetists said that the procedure needed to be aborted and the patient needed to be flipped again.Ablation was paused and entire cannula was removed at once.Patient was flipped back onto the bed and stabilized.Procedure was aborted and patient was taken to post anesthesia care unit (pacu).Per physicians assessment, the device did not contribute to the unsuccessful procedure.Post operatively, the patient was able to leave the facility with no effects.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: rlv 0015, serial number: n/a, batch/lot number: 39572248, model/catalog description: intracept rf probe, unique identifier (udi)#: (b)(4).

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50854527
• Report Number: 3006630150-2026-06989
• Device Sequence Number: 18655327
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 39327761
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 04/21/2026
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Unknown