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

Model Number RFG-NT-2000

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 09/28/2020

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 the mounting hardware was secured.Normal wear was observed on the exterior enclosure.Ac power was applied to the rf generator and the system successfully executed the power on self-test with no faults detected.Upon further investigation, thermal damage was observed on capacitor (c52) on the rf controller board (sn: (b)(4)), which would have led to the reported issue of not being able to lesion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No rework or non-conformances associated with the reported event were identified.The product passed all manufacturing, and inspection criteria at the time of manufacture.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to thermal damage on the rf controller board.Control board.

Event Description

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

• Brand Name: 4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10984847
• MDR Text Key: 220720722
• Report Number: 2184149-2020-00219
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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: 7295046
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2184149-04/22/21-001-C
• Patient Sequence Number: 1