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

Model Number	RFG-IONIC
Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
It was reported that an unknown error with the ionic generator caused the procedure to be abandoned.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
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 incident could not be conclusively determined.

• Brand Name: IONICRF¿ GENERATOR
• Common Device Name: RFG-IONIC
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22511893
• Report Number: 2184149-2025-00129
• Device Sequence Number: 8652298
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• UDI-Public: (01)05415067029317(10)10155621
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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-IONIC
• Device Catalogue Number: RFG-IONIC
• Device Lot Number: 10155621
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown