MAUDE Adverse Event Report: ABBOTT MEDICAL ENTRANT VR; NO MATCH

Model Number	CDVRA300Q
Medical Device Problem Codes	Connection Problem (2900); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During implant procedure, the right ventricular (rv) lead was difficult to be inserted in the rv port of the header of the device.The rv lead was attached but the impedance was not detectable.The rv lead was removed and attempted to be reattached to the header of the device, but this was not successful.The device was not implanted, and a new device was successfully implanted to resolve this event.The patient was stable.
Additional Manufacturer Narrative
The reported event of failure to connect was not confirmed.The reported event of impedance problem was not confirmed.The device was above elective replacement indicator (eri) upon receipt.Analysis of the device header found no anomaly contributing to reported events.Functional testing was performed, and device was within normal range of operation.

• Brand Name: ENTRANT VR
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT MEDICAL; 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: 24844074
• Report Number: 2017865-2026-07350
• Device Sequence Number: 15685089
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: (01)05415067032836(10)P000242131(17)270930
• 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): 05/01/2026

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: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: P000242131
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR.
• Patient Sex: Unknown