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	Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Date of Event	11/14/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during an intercept procedure, the patients pulse and blood pressure dropped after the first vertebral level was completed.The patient stopped breathing and the procedure was immediately aborted.The patient was turned into a supine position, intubated, and chest compressions were performed to restore the patients pulse and blood pressure.The patient was given medication to reverse anesthesia and raise their heart rate.The patient was unconscious following the procedure and the medical team assessed that the patients poor lung health and medical history of respiratory depression and hypoxia were believed to be related to the patients complications.The patient was successfully stabilized and transferred to the intensive care unit (icu).After the patient was admitted to the icu, the patient did not regain consciousness.The patient exhibited minimal brainwave activity and was thought to have hypoxic brain damage.The patient was taken off life support and passed away.There were no reported device issues.
Event or Problem Description
It was reported that during an intracept procedure, the patients pulse and blood pressure dropped after the first vertebral level was completed.The patient stopped breathing and the procedure was immediately aborted.The patient was turned into a supine position, intubated, and chest compressions were performed to restore the patients pulse and blood pressure.The patient was given medication to reverse anesthesia and raise their heart rate.The patient was unconscious following the procedure and the medical team assessed that the patients poor lung health and medical history of respiratory depression and hypoxia were believed to be related to the patients complications.The patient was successfully stabilized and transferred to the intensive care unit (icu).After the patient was admitted to the icu, the patient did not regain consciousness.The patient exhibited minimal brainwave activity and was thought to have hypoxic brain damage.The patient was taken off life support and passed away.There were no reported device issues.Additional information was received that an autopsy was not performed on this patient.The patients pre-existing poor medical condition is believed to have contributed to their death.Due to the nature of the code blue that was called during the emergency, the devices were lost and thrown away.
Event or Problem Description
It was reported that during an intracept procedure, the patients pulse and blood pressure dropped after the first vertebral level was completed.The patient stopped breathing and the procedure was immediately aborted.The patient was turned into a supine position, intubated, and chest compressions were performed to restore the patients pulse and blood pressure.The patient was given medication to reverse anesthesia and raise their heart rate.The patient was unconscious following the procedure and the medical team assessed that the patients poor lung health and medical history of respiratory depression and hypoxia were believed to be related to the patients complications.The patient was successfully stabilized and transferred to the intensive care unit (icu).After the patient was admitted to the icu, the patient did not regain consciousness.The patient exhibited minimal brainwave activity and was thought to have hypoxic brain damage.The patient was taken off life support and passed away.There were no reported device issues.Additional information was received that an autopsy was not performed on this patient.The patient's pre-existing poor medical condition is believed to have contributed to their death.Due to the nature of the code blue that was called during the emergency, the devices were lost and thrown away.
Additional Manufacturer Narrative
Correction to the mdr in block: h1.

• 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; 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: 23762848
• Report Number: 3006630150-2025-11296
• Device Sequence Number: 10080040
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/10/2026

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
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 07/15/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 05/21/2026; 08/11/2026
• 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: Life Threatening; Hospitalization; Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 320 LB
• Patient Race: White