MAUDE Adverse Event Report: ABBOTT ENTRANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA300Q

Device Problems Defective Device (2588); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

During the initial implant procedure, the left ventricular (lv) lead was unable to be connected to the header of the device.Upon investigation, it appeared that the seal in the lv port of the device was missing.The device was replaced, and the implant procedure was successfully completed.The patient was in stable condition.

Manufacturer Narrative

The reported field event of lead connection issue was confirmed.The lv septum was found to be damaged upon receipt.Septum material was observed inside the lv (is-4) set screw hex cavity, and the set screw was slightly stripped.The connection issue was consistent with having occurred during the procedure.The device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: ENTRANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16974408
• MDR Text Key: 315676005
• Report Number: 2017865-2023-20644
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: 05415067032850
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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
• Device Operator: Health Professional
• Device Model Number: CDHFA300Q
• Device Catalogue Number: CDHFA300Q
• Device Lot Number: P000166508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1