MAUDE Adverse Event Report: ABBOTT ENTRANT DR; NO MATCH

Model Number	CDDRA300Q
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During initial implant procedure, loss of capture (loc), increased pacing impedance, failure to sense, and error message was observed on the device.The device was explanted and replaced to resolve event.The patient was stable.
Additional Manufacturer Narrative
The reported complaints of failure to capture, high pacing impedance, and failure to sense were confirmed.Complaint of error message could not be confirmed.The device voltage was above elective replacement indicator (eri) upon receipt.Assessment of total projected longevity was performed, and the device was found to have excessive battery depletion.Electrical testing indicated elevated current from the hybrid.Further testing revealed an inadequate internal supply signal due to an anomalous integrated circuit (ic) on the hybrid, consistent with 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 DR
• 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: 24709454
• Report Number: 2017865-2026-05778
• Device Sequence Number: 5777646
• Product Code: NIK
• UDI-Device Identifier: 05415067032843
• UDI-Public: (01)05415067032843(10)A000157831(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/13/2026

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 Expiration Date: 05/31/2026
• Device Model Number: CDDRA300Q
• Device Catalogue Number: CDDRA300Q
• Device Lot Number: A000157831
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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
• Patient Sex: Unknown