MAUDE Adverse Event Report: RELIEVANT 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 Problems Bone Fracture(s) (1870); Spinal Column Injury (2081); Vertebral Fracture (4520)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Patient was treated with the intracept procedure at l4/l5.Patient went to er ~3 weeks later with increased pain and received a ct showing a fracture at l4.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS
• Type of Device: PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
• Manufacturer (Section D): RELIEVANT 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: 15348994
• MDR Text Key: 299174454
• Report Number: 3006789852-2022-00014
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: FG 0060
• Device Catalogue Number: RLV AK05
• Device Lot Number: 127308422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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): Disability
• Patient Age: 77 YR
• Patient Sex: Female