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); Insufficient Heating (1287)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000¿ pain management rf generator was returned for insufficient heating.Product testing revealed a thermal event on the rf control board located on the capacitor.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.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 a thermal event on the unit.

Manufacturer Narrative

Corrected information: h6.

Manufacturer Narrative

The investigation revealed that the capacitor on the rf control board failed within two years of service.

• 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: 11036534
• MDR Text Key: 222301215
• Report Number: 2184149-2020-00234
• 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,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 7452238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• 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