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

Model Number	RFG-IONIC
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced discomfort during a procedure.It was also reported that the generator had high impedances.No other adverse effects were noted.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: IONICRF¿ GENERATOR
• Common Device Name: RFG 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22164475
• Report Number: 2184149-2025-00109
• Device Sequence Number: 20704155
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• UDI-Public: (01)05415067029317(10)8846407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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
• Device Model Number: RFG-IONIC
• Device Catalogue Number: RFG-IONIC
• Device Lot Number: 8846407
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/08/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 100 KG