MAUDE Adverse Event Report: ABBOTT MEDICAL (AF-ST. PAUL) IONICRF¿ GENERATOR; RFA GENERATOR

Model Number	RFG-IONIC
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this incident, attempts were made to obtain patient information.
Event or Problem Description
It was reported an rfa procedure was abandoned due to generator would not reach a sufficient temperature and would not generate a lesion.
Additional Manufacturer Narrative
One ionic rf¿ generator sn (b)(6) was received into the lab for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.Mounting hardware was on the generator.Normal wear was observed on the exterior chassis.Ac power was applied to the ionic rf generator and the system successfully executed the power on self-test (post) with no faults detected.There were no log files to review for the reported event date.All modes were examined in this investigation.Testing of all ports was conducted while monitoring the port temps and impedance.Audible tones emitted were consistent with the modes of operation selected and no issues were observed.No hardware anomalies were detected in this investigation.The returned ionic rf¿ generator was sent to triage.The reported event was not confirmed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event could not be conclusively determined as the returned ionic rf¿ generator functioned as expected throughout the investigation.

• Brand Name: IONICRF¿ GENERATOR
• Common Device Name: RFA GENERATOR
• Manufacturer (Section D): ABBOTT MEDICAL (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL (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: 23521914
• Report Number: 2184149-2025-00176
• Device Sequence Number: 21301593
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• UDI-Public: (01)05415067029317(10)10824131
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 03/23/2026

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-IONIC
• Device Catalogue Number: RFG-IONIC
• Device Lot Number: 10824131
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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