MAUDE Adverse Event Report: Abbott Medical (AF-St. Paul) IonicRF¿ Generator; RF Generator

Model Number	RFG-IONIC
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient displayed muscle spasms without the device being turned on.No adverse patient consequences were reported, but the procedure was abandoned after the probe had been inserted in the patient.
Additional Manufacturer Narrative
E1 - reporter phone number: (b)(6).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: RF 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 ; +1(972)309-8000
• MDR Report Key: 50933628
• Report Number: 2184149-2026-00262
• Device Sequence Number: 9509113
• Product Code: GXD
• UDI-Device Identifier: 05415067029317
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 10768330
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown