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

Model Number CDHFA300Q

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); No Pacing (3268)

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

Event Date 06/01/2022

Event Type  Injury  

Event Description

During an in-clinic follow-up, high pacing impedance, high defibrillation impedance, and a loss of capture were observed on all leads.In addition, the device was unable to sense or pace.A revision procedure was performed, and when the leads were connected to the pacing system analyzer, all measurements were normal.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported field event of impedance, sensing, and pacing anomalies were confirmed.The device was above elective replacement indicator (eri) upon receipt.Functional testing in the laboratory replicated all reported events on the bench.The cause of the reported events was due to an anomalous integrated circuit in the hybrid.

• 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: 14643740
• MDR Text Key: 293628836
• Report Number: 2017865-2022-12012
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: 05415067032850
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: CDHFA300Q
• Device Catalogue Number: CDHFA300Q
• Device Lot Number: S000083451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• 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): Required Intervention