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

Model Number	DAC-NT
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
It was reported that the patient's procedure was abandoned due to non-functional adapters.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Correction b5 :additional information received reports there was no consequence to the patient as the issue was identified prior to being used in the procedure, therefore this event is no longer reportable.
Event or Problem Description
Additional information received reports there was no consequence to the patient as the issue was identified prior to being used in the procedure, therefore this event is no longer reportable.

• Brand Name: NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE
• Common Device Name: ADAPTER CABLE
• 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: 24263869
• Report Number: 2182269-2026-00046
• Device Sequence Number: 13276589
• Product Code: IKD
• UDI-Device Identifier: 05415067028884
• UDI-Public: (01)05415067028884(10)10474044
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: DAC-NT
• Device Catalogue Number: DAC-NT
• Device Lot Number: 10474044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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