MAUDE Adverse Event Report: ABBOTT ENTRANT DR; NO MATCH

Model Number	CDDRA300Q
Medical Device Problem Codes	High impedance (1291); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a device replacement procedure, an increase in pacing impedance was observed on the device.When attempting to connect a right ventricular (rv) lead into the device header, the setscrew became stripped.A new device was successfully implanted to resolve event.The patient was stable.
Additional Manufacturer Narrative
The reported event of stripped setscrew and high lead impedance issues was confirmed.Visual inspection revealed that the ventricular setscrew was stripped and fully tightened to the base of the connector socket.This condition is consistent with over rotation in the clockwise direction and continued turning while the torque wrench was not properly engaged in the setscrew inset.Following replacement of the setscrew, the lead was secured without difficulty.Subsequent electrical and mechanical testing, including lead impedance and output verification, did not identify any functional abnormalities.Longevity assessment was performed, and the device voltage was at normal range of operation with appropriate remaining longevity.

• Brand Name: ENTRANT DR
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24772912
• Report Number: 2017865-2026-06376
• Device Sequence Number: 14968698
• Product Code: NIK
• UDI-Device Identifier: 05415067032843
• UDI-Public: (01)05415067032843(10)P000243492(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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 Model Number: CDDRA300Q
• Device Catalogue Number: CDDRA300Q
• Device Lot Number: P000243492
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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