MAUDE Adverse Event Report: ABBOTT MEDICAL (AF-MINNETONKA) NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE; RF ELECTRODE

Model Number	DAC-NT
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.E1: reporter phone number (b)(6).Attempts were made to obtain physician's information but not received.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported during an ablation procedure, the electrodes were connected but were not showing up on the screen.The procedure was abandoned as a result.

• Brand Name: NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE
• Common Device Name: RF ELECTRODE
• Manufacturer (Section D): ABBOTT MEDICAL (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ABBOTT MEDICAL (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 25652910
• Report Number: 2182269-2026-00424
• Device Sequence Number: 14919121
• Product Code: IKD
• UDI-Device Identifier: 05415067028884
• UDI-Public: (01)05415067028884(10)10404044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083528
• 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): 06/29/2026

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: DAC-NT
• Device Catalogue Number: DAC-NT
• Device Lot Number: 10404044
• 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: 06/18/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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
• Patient Sex: Unknown