InjuryGXI
INTRACEPT
Received Jun 19, 2026 · Event occurred May 22, 2026
Report 3006630150-2026-04248 · MDR key 25563874
Device
Generic name
Probe, Radiofrequency Lesion
Manufacturer
Relievant Medsystems, Inc.Model number
RLV 0065Catalog number
RLV 0065
Lot number
39337692
Product problems
- Difficult to Advance
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hematoma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING AN INTRACEPT PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR A RETROPERITONEAL HEMATOMA. THE PATIENT WAS IN THE ICU FOR MULTIPLE DAYS. THE PHYSICIAN ASSESSED THAT THE HEMATOMA WAS PROCEDURE RELATED. THERE WERE NO REPORTED DEVICE ISSUES.