MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS INC INTRACEPT FLEXIBLE BI-POLAR RF PROBE; RADIOFREQUENCY LESION PROBE

Model Number	FG0038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first vb fracture following an intracept basal vertebral nerve ablation procedure that was not directly attributable to underlying pt condition.
Event or Problem Description
(b)(6) male patient with long history of low back pain underwent uncomplicated l3 and l4 intracept procedure on (b)(6) 2018 for presumed vertebrogenic pain.The patient had no history of osteoporosis and there was no clinical suspicion of bone fragility.Per the treating physician, the patient failed to improve post-procedure and had slight worsening of his usual baseline pain.Patient continued to be able to perform adls, including working full time without any medications.The lack of improvement led the physician to perform mri of the lumbosacral spine on (b)(6) 2018, showing new l4 superior endplate fracture.There was no loss of vertebral body height and no evidence of neural impingement or spinal canal compromise.The rf ablation zone did not appear to overlap with the endplate.The patient underwent uncomplicated vertebral kyphoplasty on (b)(6) 2018 with resolution of pain.

• Brand Name: INTRACEPT FLEXIBLE BI-POLAR RF PROBE
• Common Device Name: RADIOFREQUENCY LESION PROBE
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS INC; 385 moffett park drive; suite 105; sunnyvale CA 94089 1218
• MDR Report Key: 8074276
• Report Number: 3006789852-2018-00001
• Device Sequence Number: 2324751
• Product Code: GXI
• UDI-Device Identifier: 10852454006124
• UDI-Public: (01)10852454006124(17)200331(10)14985-100416
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: FG0038
• Device Lot Number: 14985-100416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRACEPT ACCESS INSTRUMENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 91