Product Card
Table Of Contents
- Device Description
- Intended Use
- Indications
- Intended Clinical Benefits
- MRI Safety Information
- Contraindications
- Warnings
- Precautions
- Implantation Procedure
- Device Modification
- Storage and Handling
- Temperature Equilibrium
- Lead Impedance
- Suboptimal Bluetooth Communication
- Disconnecting Leads and Avoiding Shock While Handling
- External Equipment for Arrhythmia Induction
- Antiarrhythmic Drugs
- Sterilization
- Damaged Package
- Environmental Hazards
- Hospital and Medical Environments
- Environmental and Medical Therapy Hazards
- Home and Industrial Environments
- Transcutaneous Electrical Nerve Stimulation
- Radiofrequency Ablation
- Electronic Article Surveillance (EAS)
- Metal Detectors
- Cellular Phones
- Adverse Events
- Pulse Generator Header
- Sensing
- Radiopaque Identification
- Implanting the Pulse Generator
- Managing and Following Patients
- Device Longevity
- Using a Magnet
- Explanting the Pulse Generator
- Out-of-Service/Explant/Patient Death Form
- Technical Support
- Additional Information
- Physical Specifications
- Battery Information
- Device Configurations
- Inductive Communication
- BLE Operating Frequencies
- Spare Parts and Accessories
- Detection Performance in the Presence of Electromagnetic Interference in Differential Mode
- Symbols
4
These devices can be programmed with Merlin™ Patient Care System equipped with Model 3330
version 25.0.2 (or greater) software. For information on programming, refer to the programmer's
on-screen help.
Intended Use
The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator
(CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular
cardioversion/defibrillation. CRT-D devices are also intended to resynchronize the right and left
ventricles.
Indications
The ICD and CDT-D devices are indicated for automated treatment of life-threatening ventricular
arrhythmias. CRT-D devices are also indicated in certain patients with congestive heart failure.
In addition, dual chamber ICD and CRT-D devices with the AT/AF detection algorithm are indicated in
patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial
tachyarrhythmias.