MAUDE Adverse Event Report: ABBOTT ENTRANT HF; NO MATCH

Model Number CDHFA300Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported, the patient received shocks and atp from the device appropriately however, the shocks and atp were unable to break the arrhythmia.The arrhythmia was terminated spontaneously.Technical support was contacted and noted this was due to the programmed settings of the device.Technical support recommended reprogramming.No intervention has been performed at this time.The patient was stable and will continue being monitored.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: ENTRANT HF
• 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: 18031944
• MDR Text Key: 326873493
• Report Number: 2017865-2023-51137
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: CDHFA300Q
• Device Lot Number: S000078547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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
• Patient Outcome(s): Other