PRODUCT CATALOG

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

Unify Quadra®

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Product Highlights

  • The Unify Quadra CRT-D and Quartet® quadripolar LV lead feature four electrodes and 10 vectors to enable LV pacing at the preferred site without compromising lead stability for better management of heart failure patients
  • 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
  • TailoredTherapy® features designed to customize treatment to each patient’s unique needs, including:
    • ShockGuard® technology with DecisionTx® programming designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
    • Enhanced sensing filter and antitachycardia pacing (ATP) before or while charging, designed to reduce shock burden and minimize inappropriate therapy
    • QuickOpt® Timing Cycle Optimization, which provides quick and effective optimization for more patients at the push of a button
    • DeFT Response® Technology, which provides more noninvasive programming flexibility in the management of DFTs and 40J delivered energy for a greater safety margin
  • Streamlined header connectors (IS4-LLLL/DF4-LLHH) reduce pocket bulk
  • Downsized device for a smaller footprint
  • QHR® battery provides greater capacity for enhanced longevity and stable charge times
Unify Quadra<sup>®</sup>


Ordering Information

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
CD3249-40 83 x 41 x 14 83 40 DF-1, IS4, IS-1
CD3249-40Q 75 x 41 x 14 81 38 DF4, IS4, IS-1

QHR is a registered trademark of Greatbatch Medical.

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: Unify Quadra pulse generators are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, Unify pulse generators are also intended to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin® Patient Care System [PCS] on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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.

Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).

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.

Item No. F00095

Customer Support: 855-478-5833

Last Updated: April 19, 2013