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

Model Number CDVRA300Q

Device Problems Data Problem (3196); No Pacing (3268)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

During an implant procedure, an error message was noted on the device.The device was eventually able to be programmed; however, there was no output from the device.The device was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported field event of pacing and impedance anomaly was confirmed.Impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be anomalous.Electrical testing revealed low internal voltage within the hybrid.An anomalous capacitor in the hybrid was found to be the cause of the impedance, sensing, pacing, and high voltage output anomalies.

Manufacturer Narrative

The reported field event of pacing and impedance anomaly was confirmed.Impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be anomalous.Electrical testing revealed low internal voltage within the hybrid.An internal hybrid anomaly was found to be the cause of the reported event.

• Brand Name: ENTRANT VR
• 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: 16249709
• MDR Text Key: 308250677
• Report Number: 2017865-2023-04265
• 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,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: P000157099
• 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: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2022
• 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