MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; No Match

Model Number CD3365-40Q

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2023

Event Type  Death  

Event Description

Related manufacturer report number: 2017865-2023-37474.It was reported through remote follow up that the implantable cardioverter defibrillator and right ventricular lead exhibited r-wave amplitude variation and under-sensing.A shock was delivered but failed to convert the patient cardiac rhythm back to sinus.Following the shock delivery, there was not sufficient sensing to deliver additional therapy.The patient passed away.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: No Match
• 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: 17451018
• MDR Text Key: 320304604
• Report Number: 2017865-2023-37475
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: CD3365-40Q
• Device Lot Number: A000004671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2015
• 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: QUARTET; TENDRIL
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male