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

Model Number RFG-NT-2000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000¿ pain management rf generator was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.It was also verified that all internal components were secured, and normal wear was noted on the chassis exterior.Inspection of the device internal components revealed a discolored, charred and electrically failed capacitor at the c49 location, which confirms the field reported issue.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 information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to abnormal functionality of the radio frequency control board.

Event Description

This report is to advise of an event observed during analysis confirming a thermal event on the radio frequency control board of the generator.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12748169
• MDR Text Key: 279984392
• Report Number: 2184149-2021-00353
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 6295229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1