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

Model Number	RFG-NT-2000
Medical Device Problem Codes	Insufficient Heating (1287); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the generator stopped working during a procedure.As a result, the procedure was abandoned.
Additional Manufacturer Narrative
The reported event was confirmed.An error message was noted; however, further investigation was not confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided, the reported event was confirmed, and the root cause remains unknown.

• Brand Name: 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: NT 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17680458
• Report Number: 2184149-2023-00169
• Device Sequence Number: 20658411
• Product Code: GXD
• UDI-Device Identifier: 05415067022417
• UDI-Public: 05415067022417
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: RFG-NT-2000
• Device Lot Number: 6812488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2015
• 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
• Patient Sex: Unknown