INTRACEPT RF PROBE
Received Jun 26, 2026 · Event occurred May 20, 2026
Report 3006630150-2026-04425 · MDR key 25638419
Device
Generic name
Probe, Radiofrequency Lesion
Manufacturer
Relievant Medsystems, Inc.Model number
RLV 0015Catalog number
RLV 0015
Lot number
38907755
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Male
- Muscle Weakness/Atrophy
- Nerve Damage
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE AT THE L1 AND L2 VERTEBRAL LEVELS. DURING THE PROCEDURE, VISUALIZATION OF ANATOMICAL LANDMARKS WAS CHALLENGING DUE TO THE PATIENTS ANATOMICAL CHARACTERISTICS AND SUBOPTIMAL FLUOROSCOPIC IMAGING. AT THE L1 LEVEL, THE RIGHT PEDICLE WAS TRAVERSED, AND A CHANNEL WAS CREATED EXTENDING INTO WHAT APPEARED TO BE THE POSTERIOR HALF OF THE VERTEBRAL BODY. THE PROBE WAS POSITIONED TO THE PHYSICIANS SATISFACTION, AND A STANDARD ABLATION WAS PERFORMED. AT THE L2 LEVEL, THE LEFT PEDICLE WAS TRAVERSED, AND A CHANNEL WAS CREATED INTO WHAT APPEARED TO BE THE POSTERIOR THIRD OF THE VERTEBRAL BODY. THE PROBE WAS PLACED TO THE PHYSICIANS SATISFACTION, AND A TARGETED ABLATION WAS PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WEAKNESS AND WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE FOR REHABILITATION. BASED ON PHYSICIANS ASSESSMENT HE PROCEDURE COULD HAVE CONTRIBUTED TO THE PATIENTS WEAKNESS AND IT COULD HAVE BEEN CAUSED BY A THERMAL NERVE INJURY. THE PATIENT HAS SINCE BEEN DISCHARGED AND THE WEAKNESS IS IMPROVING, HE IS STABLE.