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

Model Number	RFG-IONIC
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an rfa procedure, an error was displayed due to grounding pad not attaching.Troubleshooting was done but the issue persisted.The procedure was abandoned.There were no adverse patient consequences.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Additional Manufacturer Narrative
The reported event was not confirmed.The logs on the reported event date revealed a grounding pad detection issue; however, the returned ionic rf¿ generator functioned as expected throughout the investigation.

• Brand Name: IONICRF¿ GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• 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: 22532417
• Report Number: 2184149-2025-00132
• Device Sequence Number: 17998511
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• UDI-Public: (01)05415067029317(10)7820015
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201610
• 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,Followup
• Report Date (Section B): 09/04/2025

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: 7820015
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 09/03/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/08/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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
• Patient Sex: Female
• Patient Weight: 67 KG