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

Model Number CD3369-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 12/05/2022

Event Type  Death  

Event Description

It was reported that a patient was found deceased after experiencing multiple tachycardia episodes that did not meet the criteria for their implantable cardioverter defibrillator (icd) to deliver therapy.It was believed to be a result of how the device was programmed, and not due to a device malfunction.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16063353
• MDR Text Key: 306289396
• Report Number: 2017865-2022-50919
• Device Sequence Number: 1
• Product Code: NIK
• 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 Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000024917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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 RIGHT VENTRICULAR LEAD; QUARTET LEFT VENTRICULAR LEAD; TENDRIL RIGHT ATRIAL LEAD
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Female