CDDRA500T Gallant Dual Chamber ICD User Guide
- June 15, 2024
- Gallant
Table of Contents
CDDRA500T Gallant Dual Chamber ICD User Guide
CDDRA500T
Compatible with myMerlinPulse™ app
Product Highlights
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Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption
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40J delivered energy safety shock option for enhanced safety margin
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DeFT Response™ technology offers noninvasive programming options to optimize rescue therapy to each patient’s unique physiology and changing conditions
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VF Therapy Assurance decreases time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable
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Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone extends the programming options for terminating tachyarrhythmias without a
high-voltage shock -
ShockGuard™ technology with DecisionTx™ programming designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
– SecureSense™ RV lead noise discrimination algorithm detects sustained lead noise and records short bursts of oversensing that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
– Far Field MD™ morphology discrimination and chamber onset discrimination enhance SVT and VT discrimination for reduced inappropriate therapies -
SenseAbility™ sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
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DynamicTx™ over-current detection algorithm automatically changes shock configurations to ensure delivery of high-voltage therapy when high current is detected
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MRI-Ready device tested in combination with
MR Conditional leads for full-body scans using a 1.5T or 3T (Tesla) field strength MRI Scanner* -
Cold can programmability provides an additional RV-SVC shock configuration to decouple the can from the shocking vector parameters
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The CorVue™ thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition
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Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone
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Physiologic rate responsive AV Delay and PVARP
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Dual patient notification: audio notification through the device and visual notification via myMerlinPulse app
Ordering Information
Contents: Cardiac Pulse Generator
*See MRI Scan Parameters in MRI-Ready Systems Manual.
Product Specifications
† For additional information about specific MR Conditional ICDs and leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to the Abbott MRI-Ready Systems Manual at medical.abbott/manuals.
Rx Only
Brief Summary: This product is intended for use by or under the direction of a
Physician. 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.
Intended Use: The Implantable Cardioverter Defibrillator (ICD) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.
Indications: The ICD devices are indicated for automated treatment of life- threatening ventricular arrhythmias.
In addition, dual chamber ICD 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.
MR Conditional ICDs are conditionally safe for use in the MRI environment when
used in a complete MR Conditional system and according to instructions in the
MRI-Ready Systems manual.
Scanning under different conditions may result in severe patient injury, death
or device malfunction.
The myMerlinPulse™ mobile application is indicated for use by patients with
supported Abbott Medical implanted heart devices.
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.
The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.
Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle),
Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability.
Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.
No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.
ABBOTT
15900 Valley View Court, Sylmar, CA 91342
Tel: +1 818 362 6822
Abbott.com
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective
owner.
© 2024 Abbott. All Rights Reserved.
MAT-2400586 v2.0 | Item approved for U.S. only.
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References
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