MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

Model Number	RFG-NT-1100
Medical Device Problem Code	No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that the generator's touchscreen was uncalibrated during a procedure.As a result, the procedure was abandoned and the physician performed an opioid infiltration instead.

• Brand Name: 3 LESION NT1100¿ 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20588053
• Report Number: 2184149-2024-00178
• Device Sequence Number: 6529080
• Product Code: GXD
• UDI-Device Identifier: 05415067022370
• UDI-Public: (01)05415067022370(10)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052878
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: RFG-NT-1100
• Device Catalogue Number: RFG-NT-1100
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown