Promote™ + Cardiac Resynchronisation Therapy Defibrillator (CRT-D)
CARDIOVASCULAR
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Promote™ +

Cardiac Resynchronisation Therapy Defibrillator (CRT-D)

Promote™+

PRODUCT HIGHLIGHTS

  • The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws
  • Triple redundancy safety platform is designed to minimise risk and increase security and patient comfort through multiple hardware and software system safeguards
  • 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
  • AT/AF Alerts can be programmed to notify patients and their clinics when a programmed AT/AF threshold or continuous episode duration has been exceeded, or when a high ventricular rate accompanies the AT/AF episode
  • Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery, lead-related complications and more
  • QuickOpt™ timing cycle optimisation provides quick and effective optimisation for more patients at the push of a button
  • VectSelect™ programmable LV pulse configuration (LV ring-RV coil, LV tip- RV coil or LV bipolar) may be adjusted noninvasively via the programmer
  • DeFT Response™ technology tools provide more clinically proven, noninvasive options for managing high DFTs

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD3211-36 81 x 50 x 14 82 43 DF1 IS-1
CD3211-36Q 75 x 50 x 14 82 42 DF4 IS-1; DF4


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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