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	Respiratory Insufficiency (4462)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was sedated and experienced a desaturation event during a procedure.The patient was subsequently intubated.Zero levels were completed before the issue arose and the pedicle was still being traversed.Ablation was not started before this event occurred.The procedure was completed successfully and the patient is doing well postoperatively with no complications.
Event or Problem Description
It was reported that the patient was sedated and experienced a desaturation event during a procedure.The patient was subsequently intubated.Zero levels were completed before the issue arose and the pedicle was still being traversed.Ablation was not started before this event occurred.The procedure was completed successfully and the patient is doing well postoperatively with no complications.The devices were discarded by the medical facility and will not be returned for device analysis.
Additional Manufacturer Narrative
Correction to initial emdr in block d4.
Event or Problem Description
It was reported that the patient was sedated and experienced a desaturation event during a procedure.The patient was subsequently intubated.Zero levels were completed before the issue arose and the pedicle was still being traversed.Ablation was not started before this event occurred.The procedure was completed successfully and the patient is doing well postoperatively with no complications.The devices were discarded by the medical facility and will not be returned for device analysis.

• 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: 21735549
• Report Number: 3006630150-2025-02031
• Device Sequence Number: 8798026
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)261022(10)35309128
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• 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 Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 35309128
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 06/17/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/24/2025; 07/10/2025
• Date Device Manufactured: 10/22/2024
• 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