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

Model Number CD3369-40Q

Device Problems Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problems Dyspnea (1816); Dizziness (2194)

Event Date 10/20/2022

Event Type  Injury  

Event Description

It was reported that patient¿s device entered vvi backup mode on three separate occasions due to data corruption.Patient had light headed, dizzy and short of breath upon losing atrioventricular (av) synchrony when the device would go into vvi backup mode.The device was explanted and replaced.The patient went home without any issue.

Manufacturer Narrative

The reported event of backup operation could not be confirmed based on the available device data.Upon receipt, the device was interrogated on a programmer and normal communication was established.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation could not be reproduced.The cause of the reported event could not be determined.

• Brand Name: QUADRA ASSURA MP¿
• 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: 15757253
• MDR Text Key: 303292984
• Report Number: 2017865-2022-44765
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000093060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 64 KG