MAUDE Adverse Event Report: NEUROTHERM, INC 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number RFG-NT-2000

Device Problems Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During a radiofrequency (rf) ablation procedure, the rf generator released rf therapy without being selected.After placing the probe in the treatment location, the user changed the generator settings from sensory testing to pulsed rf.Rf energy was delivered, however; the patient was startled as the rf was not expected.The probe was disconnected from the generator and the generator was stopped when this occurred to prevent any further delivery of rf energy.An error message was displayed at this time as well.The patient remained stable throughout the duration of the procedure and the procedure was continued and completed.There were no adverse patient consequences.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h4, h6.One nt 2000 neurotherm rf generator was received.The generator was connected to an external power source and the generator powered on successfully.The reported uncommanded rf delivery was able to be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the provided information and the observed symptoms, the issue was isolated to an abnormal functioning of the third rf amplifier board.Re-calibration of the rf amplifier board resolved the reported problem.

Manufacturer Narrative

Corrected information: h6.Additional information: g4, g7, h2.

• Brand Name: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• MDR Report Key: 9918061
• MDR Text Key: 202551108
• Report Number: 3002953813-2020-00015
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (y/n): N
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFG-NT-2000
• Device Catalogue Number: RFG-NT-2000
• Device Lot Number: 9800229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1