MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problems Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)

Patient Problem Arrhythmia (1721)

Event Date 01/13/2023

Event Type  Injury  

Event Description

It was reported the patient was admitted to the intensive care unit due to a ventricular tachycardia storm.The device provided appropriate shocks, however, the shocks were unsuccessful in terminating the electrical storm.The high voltage therapy on the device was deactivated and an external defibrillator was used to terminate the arrhythmia.Additionally, following the event, the device was in back up mode.Technical support was contacted and recommended reprogramming to resolve the event.Technical support suspected the back up mode was due to the use of the external defibrillator.The device was reprogrammed.There were no consequences to the patient due to the device.

Manufacturer Narrative

The reported event of the patient being in a ventricular tachycardia (vt) storm that was unable to be terminated successfully by the device was confirmed.The device delivered multiple atp and high voltage therapy for repeated arrhythmia, but was unsuccessful.It was confirmed that the device was sensing appropriately during this time and was performing by design.

• Brand Name: QUADRA ASSURA MP ICD
• 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: 16235514
• MDR Text Key: 308028271
• Report Number: 2017865-2023-02981
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CD3371-40QC
• Device Lot Number: A000076230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• 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