INTRACEPT RF PROBE
Report
- Report Number
- 3006630150-2025-06315
- Event Type
- Injury
- Date Received
- August 8, 2025
- Date of Event
- July 16, 2025
- Report Date
- September 9, 2025
- Manufacturer
- RELIEVANT MEDSYSTEMS, INC.
- Product Code
- GXI
- UDI-DI
- 00852454006219
- PMA / PMN Number
- K180369
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A2: PATIENTS AGE IS OVER 60 YEARS OLD, BUT EXACT AGE IS UNKNOWN.
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
IT WAS REPORTED THAT THE PATIENT HAD SEVERE DYSESTHETIC LEG PAIN THAT OCCURRED TWO WEEKS AFTER UNDERGOING AN INTRACEPT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS HOSPITALIZED FOR A FEW DAYS DUE TO SEVERE PAIN. POST-OPERATIVE IMAGING WAS PERFORMED AND SHOWED NO NERVE COMPRESSION OR COMPLICATIONS. IT WAS FOUND THAT THE PATIENT HAD A SELECTIVE NERVE ROOT BLOCK AND THE PAIN WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE A PRIOR HISTORY OF LEG PAIN OR MRI FINDINGS OF NERVE IMPINGEMENT.
IT WAS REPORTED THAT THE PATIENT HAD SEVERE DYSESTHETIC LEG PAIN THAT OCCURRED TWO WEEKS AFTER UNDERGOING AN INTERCEPT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS HOSPITALIZED FOR A FEW DAYS DUE TO SEVERE PAIN. POST-OPERATIVE IMAGING WAS PERFORMED AND SHOWED NO NERVE COMPRESSION OR COMPLICATIONS. IT WAS FOUND THAT THE PATIENT HAD A SELECTIVE NERVE ROOT BLOCK AND THE PAIN WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1883466 | INTRACEPT RF PROBE | PROBE, RADIOFREQUENCY LESION | GXI | RELIEVANT MEDSYSTEMS, INC. | RLV 0015 | 00852454006219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Hospitalization |