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

Model Number	CDHFA300D
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial implant procedure, the set screw was unable to be tightened on the device.The device was explanted and replaced to resolve event.The patient was stable with no consequences.
Additional Manufacturer Narrative
Reported event of loose or intermittent connection was confirmed.The device was above elective replacement indicator (eri) upon receipt.Analysis revealed the dislodgement of the left ventricular contact spring within port, which caused reported event preventing insertion of lead.Manufacturing investigation was performed with undetermined cause.Functional testing performed after reinstalling contact spring was found to be normal.A manufacturing process anomaly may have occurred contributing to the reported event.A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 24438710
• Report Number: 2017865-2026-03737
• Device Sequence Number: 16007578
• Product Code: NIK
• UDI-Device Identifier: 05415067050120
• UDI-Public: (01)05415067050120(10)A000181547(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/27/2026

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: A000181547
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2025
• 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