MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

Model Number	RFG-NT-2000
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this incident, attempts were made to obtain complete event and patient information.Further information was requested but not received.
Event or Problem Description
It was reported that during a rfa procedure on (b)(6) 2025, the healthcare professional received an error message instead an impedance value when attempting perform a burn on a patient.As such, the procedure was cancelled.
Additional Manufacturer Narrative
An rfa generator issue was reported to abbott.It was determined that during a rfa procedure, high/ low impedances were observed.The procedure was cancelled.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: RF GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21673203
• Report Number: 2184149-2025-00056
• Device Sequence Number: 8164490
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: (01)05415067022417(10)7736694
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RFG-NT-2000
• Device Catalogue Number: RFG-NT-2000
• Device Lot Number: 7736694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 03/23/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown