MAUDE Adverse Event Report: ABBOTT ENTRANT HF; No Match

Model Number	CDHFA300Q
Medical Device Problem Codes	Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a remote follow-up, post-sensed t-wave oversensing (pstwos) and decreased sensing variation were observed on the device.Technical support was contacted and recommended reprogramming to resolve the event, however no intervention has been performed.The patient was stable and will continue to be monitored.

• Brand Name: ENTRANT 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: 25665302
• Report Number: 2017865-2026-13521
• Device Sequence Number: 5701039
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: (01)05415067032850(10)P000253821(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/30/2026

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: CDHFA300Q
• Device Catalogue Number: CDHFA300Q
• Device Lot Number: P000253821
• 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: 06/17/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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