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 Type  Injury  

Event Description

Patient had a l3 compression fracture 61 days post-op.Patient was subsequently treated with a l3 kyphoplasty/teriparatide.Intracept treatment occurred on l1-l3 levels.

• 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: 14740041
• MDR Text Key: 294486822
• Report Number: 3006789852-2022-00007
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/18/2022
• 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; Disability
• Patient Age: 84 YR