MAUDE Adverse Event Report: ABBOTT ENTRANT VR; No Match

Model Number CDVRA300Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient experienced ventricular tachycardia (vt) and high-voltage (hv) therapy was delivered by the device, but was not able to terminate the vt.Afterwards, a defibrillation threshold (dft) test was successfully performed and the induced ventricular fibrillation was able to be terminated.The patient was stable and will continue to be monitored.

• Brand Name: ENTRANT VR
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17495577
• MDR Text Key: 320854830
• Report Number: 2017865-2023-37972
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: 05415067032836
• 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
• Report Date: 08/09/2023

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 Expiration Date: 08/31/2023
• Device Model Number: CDVRA300Q
• Device Lot Number: P000130419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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