MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One 4 lesion nt2000 pain management rf generator was received 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 all external hardware secured, no physical damage observed on the display panel or the exterior casing.Inspection of the internal components revealed a failed capacitor at the c50 location on the radio frequency control board which resulted in the thermal event identified.No functional testing was performed due to the physical damage previously identified.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was 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 with 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; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11346057
• MDR Text Key: 232504812
• Report Number: 2184149-2021-00049
• 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

• 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: 7536237
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA 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