MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Model Number RFG-NT-2000

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000¿ pain management rf generator was received into the lab for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.All of the mounting hardware was secured.Normal wear was observed on the exterior enclosure.The generator powered on, passed the self-test and booted to the main application screen, but a beeping noise was noticed throughout the boot-up.Visual inspection of the internal components revealed a thermal event at capacitor c49 on the rf controller board.The rf controller board was temporarily replaced with a good known unit and the issue was resolved.Based on the information provided to abbott and the investigation performed, the cause for the reported event was isolated to the rf control board.

Event Description

This report is to advise of an event observed during analysis confirming thermal decomposition of the generator.

Manufacturer Narrative

Corrected information: h6.

• Brand Name: 4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11018692
• MDR Text Key: 221729676
• Report Number: 2184149-2020-00231
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 7461049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2184149-04/22/21-001-C
• Patient Sequence Number: 1