INTRACEPT RF PROBE
Received Jun 26, 2026 · Event occurred Apr 26, 2026
Report 3006630150-2026-04446 · MDR key 25644165
Device
Generic name
Probe, Radiofrequency Lesion
Manufacturer
Relievant Medsystems, Inc.Model number
RLV 0015Catalog number
RLV 0015
Lot number
38568276
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Female
- Fall
- Pain
- Vertebral Fracture
- Cramp(s) /Muscle Spasm(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BASIVERTEBRAL NERVE (BVN) RADIOFREQUENCY ABLATION PROCEDURE AND FELT GREAT AFTER THE PROCEDURE. LESS THAN A WEEK LATER, SHE EXPERIENCED SEVERE PAIN, DISCOMFORT, AND MUSCLE SPASMS IN HER LOWER BACK, AND STATED SHE HAD FALLEN A FEW TIMES. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS INSTRUCTED TO INCREASE HER DOSE OF PAIN MEDICATION AND WAS SENT HOME. IMAGING TAKEN REVEALED A COMPRESSION FRACTURE AT L4. IT IS UNKNOWN IF THE FALLS WERE RELATED TO THE FRACTURE AS THE PATIENT COULD NOT REMEMBER FALLING. THE PHYSICIAN ASSESSED THAT THE BVN PROCEDURE MIGHT HAVE CAUSED THE COMPRESSION FRACTURE.