MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; No Match

Model Number CD3369-40Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the patient experienced ventricular fibrillation, and the device did not deliver a shock.It was identified that the patient's device was programmed to deliver a shock after several intervals, which did not meet and returned to sinus.Noise was also noted on the discrimination channel and occasional ventricular undersensing.Programming changes were made.The patient was asymptomatic.

• Brand Name: QUADRA ASSURA MP ICD
• 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: 17703953
• MDR Text Key: 323088436
• Report Number: 2017865-2023-42447
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: CD3369-40Q
• Device Lot Number: A000035944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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: GUIDANT RV LEAD; QUARTET LV LEAD; TENDRIL RA LEAD
• Patient Sex: Male