MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-MINNETONKA) NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE; CABLE, ELECTRODE

Model Number	DAC-NT
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2182269-2024-00009.It was reported that during a procedure a message was received stating the electrode has been changed.As such, the treatment was stopped, and the patient was changed to medication treatment.Reportedly, there were no adverse consequence to the patient.A replacement adapter and same needle were used but the issue persisted.However, when troubleshooting with a representative¿s adapter cable, the issue was resolved.
Additional Manufacturer Narrative
E1: reporter phone number:(b)(6).
Additional Manufacturer Narrative
The reported connection issue was confirmed.An error message was noted on the generator when a simulated lesion test was attempted with the returned cable.The cable was dissected, and the constantan wire was found fractured just proximal to the distal connector, consistent with the reported connection issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured constantan wire remains unknown.

• Brand Name: NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19121544
• Report Number: 2182269-2024-00008
• Device Sequence Number: 18054239
• Product Code: IKD
• UDI-Device Identifier: 05415067028884
• UDI-Public: (01)05415067028884(10)8076556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DAC-NT
• Device Lot Number: 8076556
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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