MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Death (1802)

Event Date 03/23/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the implantable cardioverter-defibrillator successfully delivered therapy when the patient experienced ventricular fibrillation (vf).Non sustained right ventricular oversensing episodes were observed prior to the shock delivered that showed undersensing on the discrimination channel.No therapies were inhibited.After the shock, there were episodes of a rhythm similar to a bigeminal rhythm, but the signals were not seen on the far field left or right channels.These following signals were likely not true signals from the heart and also no longer happening.The patient was hospitalized with symptoms of cardiac arrest.Programming changes were discussed but could not be performed as the patient passed away on the next day.The device did not deliver therapy for ten minutes and caused the patient to be intubated.The patient never recovered.The device might cause or contribute to patient's death.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9950829
• MDR Text Key: 187354225
• Report Number: 2938836-2020-02598
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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: 01/31/2022
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000093023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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; Hospitalization