MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; No Match

Model Number CD3371-40QC

Device Problems Failure to Deliver Shock/Stimulation (1133); Over-Sensing (1438); Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Date 12/13/2023

Event Type  Death  

Event Description

It was reported that the patient passed away due to ventricular fibrillation.Oversensing and undersensing were noted on the device and no high voltage therapy was delivered during ventricular tachycardia (vt) events.Abbott technical support was contacted, session records were reviewed, and the analysis indicated that no high voltage therapy was received due to the programming of the device.Additionally, the oversensing and undersensing were not suspected to have contributed to the lack of high voltage therapy and may have been indicative of the dying heart.Session record analysis indicated no malfunction was suspected on the device or leads.

• Brand Name: QUADRA ASSURA MP 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: 18440466
• MDR Text Key: 331858224
• Report Number: 2017865-2024-00275
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: A000105148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2021
• 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
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUARTET; TENDRIL STS
• Patient Outcome(s): Death