MAUDE Adverse Event Report: RELIEIVANT MEDSYSTEMS, INC. INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES

Model Number FG 0060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Column Injury (2081)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Missing data is due to the manufacturer learning of the event prior to the patient being scheduled for a surgical intervention to investigate.There was no initial complaint concerning the medical device used so there was no record of which component device was involved in the apparent pedicle breach.The manufacturer will follow-up to get additional data on the patient and the outcome of the surgical intervention.

Event Description

A patient following basivertebral nerve ablation experienced post op pain, including radiculopathy and neuritis down the right side.The physician treated the patient with a steroid dose pack.The patient received an mri and the physician suspected that he may have nicked a piece of bone which lifted into the foramen.As the steroid treatment did not resolve the pain, patient is undergoing an exploratory procedure to determine cause of the pain.Outcome of exploratory procedure not known at this time.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS
• Type of Device: PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
• Manufacturer (Section D): RELIEIVANT MEDSYSTEMS, INC.; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer Contact: thomas slater ; 1230 midas way; suite 200; sunnyvale, CA 94085-4068 ; 6503681000
• MDR Report Key: 12485784
• MDR Text Key: 271945406
• Report Number: 3006789852-2021-00001
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG 0060
• Device Catalogue Number: RLV AK05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR