Unify™ Cardiac Resynchronisation Therapy Defibrillator (CRT-D)
CARDIOVASCULAR
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Unify™

Cardiac Resynchronisation Therapy Defibrillator (CRT-D)

Merlin at home compatible

PRODUCT HIGHLIGHTS

  • Smallest footprint of any HV device available
  • The CorVue™ congestion monitoring feature monitors the intrathoracic impedance in multiple vectors for improved accuracy, and it provides the option for both patient and physician alerts
  • 40 J delivered energy provides unsurpassed energy for defibrillation
  • ShockGuard™ technology with DecisionTx™ programming, designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant
  • DF connector is designed simplifies the implant by decreasing the defibrillation connections into a single terminal pin and reducing the number of set screws.
  • QHR™* chemistry battery provides greater capacity for enhanced longevity and charge times
  • Triggered pacing with BiV™ Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event
  • Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present, thereby promoting a high degree of ventricular pacing

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD3235-40 79 x 40 x 14 78 36 DF1 IS-1
CD3235-40Q 73 x 40 x 14 77 36 DF4 DF4; IS-1

*QHR is a trademark of Greatbatch, LTD.


Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) are also intended to resynchronise 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.

Item GMCRM910EN

Last Updated: January 02, 2019

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