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

Model Number	RFG-IONIC
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a grounding pad malfunction during the rfa procedure and as a result, the procedure was aborted.No patient complications were reported.
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain patient information.Further information was requested but not received.
Additional Manufacturer Narrative
It was reported that the rep is at an account with an ionic generator prompting "grounding pad detached".Rep reported they have tried 3 grounding pads and the message has persisted.They have tried different locations on the patient and confirmed to wipe the skin prior to placing the grounding pad.Rep performed two grounding pad tests with a new grounding pad and a reusable probe.The procedure was canceled and the patient was sent home.No further intervention is planned.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.

• 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: 24283425
• Report Number: 2184149-2026-00030
• Device Sequence Number: 18222266
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• UDI-Public: (01)05415067029317(10)7820001
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/02/2026

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-IONIC
• Device Catalogue Number: RFG-IONIC
• Device Lot Number: 7820001
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown