PRODUCT CATALOG

Cardiac Rhythm Management | Cardiac Resynchronization Therapy (CRT) Devices | CRT Defibrillator

Quadra Assura

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Highlights

  • MRI Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5 T (Tesla) field strength MRI Scanner*
  • The Quadra Assura CRT-D and Quartet™ quadripolar LV pacing lead feature four pacing electrodes and 10 pacing vectors to provide more options and greater control to address implant complications such as diaphragmatic stimulation and high pacing thresholds
  • VectSelect Quartet™ multivector testing feature offers a streamlined workflow to identify, test and program the patient’s pacing vector by evaluating the site of latest activation on the LV lead
  • DynamicTx™ Over-Current Detection Algorithm automatically changes shock configurations to ensure delivery of high voltage therapy when high current is detected
  • Cold Can programmability provides an additional RV-SVC Shock Configuration to decouple the can from the shocking vector parameters
  • ShockGuard™ technology with DecisionTx™ programming designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
     – SecureSense™ RV lead noise discrimination detects sustained and records short bursts of lead noise that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
     – Far Field MD™ morphology discriminator and Chamber Onset discrimination designed to improve SVT and VT discrimination for reduced inappropriate therapies
  • Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a highvoltage shock
  • SenseAbility™ sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
  • DF4 connector designed to streamline defibrillation connections into a single terminal pin and reduce the number of set screws
  • Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin
  • DeFT Response™ technology offers noninvasive options for managing high DFTs with or without induction testing
  • QHR chemistry battery provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries
  • Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery, lead-related complications and more
  • The CorVue™ Thoracic Impedance Monitoring feature utilizes multiple vectors to measure transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition
  • QuickOpt™ timing cycle optimization provides quick and effective optimization at the push of a button
Qudra Assura


Ordering Information

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
CD3365-40Q 74 x 41 x 14 80 38 DF4, IS4, IS-1

*See MRI scan restrictions

Rx Only

 

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure.

 

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

 

Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac events including T waves, P waves or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-QD-1017-0060

Customer Support: 855-478-5833

Last Updated: December 19, 2017