FDA Adverse Event
Malfunction
Summary report: N
INTRACEPT
MDR report key: 24868828
·
Received April 14, 2026
Report
- Report Number
- 3006630150-2026-02320
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- March 16, 2026
- Report Date
- April 14, 2026
- Manufacturer
- RELIEVANT MEDSYSTEMS, INC.
- Product Code
- GXI
- UDI-DI
- 00852454006301
- PMA / PMN Number
- K222281
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD EXTREMELY HARD BONE DURING AN INTRACEPT PROCEDURE. ONE LEVEL WAS COMPLETED SUCCESSFULLY, BUT DURING THE SECOND LEVEL, THE J-STYLET WAS SHOT ANTERIOR. UPON REMOVAL OF THE J-STYLET, IT WAS NOTICED THAT A SMALL AMOUNT OF PEEK FROM THE CURVED CANNULA MAY HAVE BEEN LEFT BEHIND INSIDE THE PATIENT. IT IS UNKNOWN IF THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 933657 | INTRACEPT | PROBE, RADIOFREQUENCY LESION | GXI | RELIEVANT MEDSYSTEMS, INC. | RLV 0045 | 38517754 | 00852454006301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |