MAUDE Adverse Event Report: ABBOTT ENTRANT BIPOLAR DF4 HF; NO MATCH

Model Number	CDHFA300D
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial implant procedure, the pacing impedance increased when the lead was connected to the header of the device.A new device was selected and connected to the lead to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of high pacing impedance was not confirmed.The device was received at beginning of life (bol), with normal outputs and telemetry communication.Visual inspection of the device and its connectors indicated normal device characteristics.Electrical and mechanical tests performed including lead impedance, sensing, and output verification did not identify any functional issues.The reported events could not be reproduced.

• Brand Name: ENTRANT BIPOLAR DF4 HF
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23987114
• Report Number: 2017865-2026-00455
• Device Sequence Number: 4630692
• Product Code: NIK
• UDI-Device Identifier: 05415067050120
• UDI-Public: (01)05415067050120(10)S000103550(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030054
• 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): 03/10/2026

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: CDHFA300D
• Device Catalogue Number: CDHFA300D
• Device Lot Number: S000103550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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
• Patient Sex: Unknown