MAUDE Adverse Event Report: ABBOTT ENTRANT¿ VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	CDVRA300T
Medical Device Problem Codes	Break (1069); High impedance (1291); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the initial implant procedure, the set screw of the device was unable to be tightened resulting in high pacing impedance.Additional attempts were made to tighten the set screw and migration of the header septum and the set screw within the device header was observed.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of set screw/septum anomaly and high impedance were confirmed.The device was above elective replacement indicator (eri) upon receipt.Visual inspection found the septum was removed.Analysis revealed the ventricular set screw contained septum material inside the hex cavity.This material in the hex cavity prevented full insertion of the torque driver and was the cause of the set screw anomaly.The high impedance was a result of the set screw anomaly.The set screw/septum anomaly and high impedance were consistent with having occurred during the procedure.

• Brand Name: ENTRANT¿ VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 22009641
• Report Number: 2017865-2025-53479
• Device Sequence Number: 20131821
• Product Code: LWS
• UDI-Device Identifier: 05415067049414
• UDI-Public: (01)05415067049414(10)S000098716(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/20/2025

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: 08/31/2026
• Device Model Number: CDVRA300T
• Device Catalogue Number: CDVRA300T
• Device Lot Number: S000098716
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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