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

Model Number CD3361-40QC

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Type  Death  

Manufacturer Narrative

Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

The patient expired after the device failed to provide defibrillation therapy due to undersensing of ventricular tachycardia.However, based on the current information available, the physician has not indicated whether or not the device experienced a malfunction or was performing as expected based on its programmed settings.The cause of death remains unknown at this time.Further information was requested, but not received.

Event Description

Additional information received indicated the patient passed away due to heart failure.The physician reviewed the electrocardiograms and does not allege a malfunction caused or contributed to the patient's death.Furthermore, the abbott technical support alleged the device was performing as expected based upon its programmed settings.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10612948
• MDR Text Key: 209367656
• Report Number: 2938836-2020-08469
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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: 02/28/2021
• Device Model Number: CD3361-40QC
• Device Lot Number: A000075220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death