MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; NO MATCH

Model Number CD3367-40QC

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/05/2024

Event Type  Death  

Event Description

It was reported that the patient was hospitalized for heart failure.During atrial and ventricular tachyarrhythmias, the device delivered appropriate high voltage therapy that did not terminate the arrhythmia.The patient was externally defibrillated.The external defibrillation was not effective and the patient passed away.Session records were provided and analyzed by abbott technical support.Undersensing due to decreased sensing during an agonal rhythm was observed.The physician did not allege any malfunction of the device.

Manufacturer Narrative

The reported field event of sensing and pacing anomaly was not confirmed in the lab.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA ICD
• 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: 19144146
• MDR Text Key: 340605234
• Report Number: 2017865-2024-39117
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508322
• UDI-Public: (01)05414734508322(10)A000147306(17)250831
• 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: 05/31/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: CD3367-40QC
• Device Lot Number: A000147306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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): Death
• Patient Sex: Male