Medtronic Claria™, Amplia™, Compia™ MRI SureScan™ Cardiac Resynchronization Therapy Defibrillators
Model Numbers: DTMA1QQ, DTMA1Q1, DTMA1D4, DTMA1D1, DTMB1QQ, DTMB1Q1, DTMB1D4, DTMB1D1, DTMC1QQ, DTMC1D1
Table of Contents
- How does an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) defibrillator system work? 1
- What are the different types of ICD systems? 1
- What are the different therapies that an ICD can deliver? 1
- What are the dimensions of the Claria™, Amplia™, Compia™ MRI SureScan™ defibrillators? 3-12
- What are some of the technology features in the Claria™, Amplia™, Compia™ MRI SureScan™ defibrillator? 1,3-12
- How often does the heart doctor check the defibrillator? 1
How does an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) defibrillator system work?
Your heart device has two main functions. It continuously monitors your heart rhythm and it delivers therapies. If your heartbeat is too slow, too fast, or irregular, your heart device delivers pulses of electricity directly to your heart through the implanted lead, an insulated wire. This therapy helps your heart to beat in a regular rhythm. Your heart device can deliver different therapies, depending on the type of abnormal heart rhythm it detects.
What are the different types of ICD systems?
For a single chamber ICD, a single lead is placed inside the right ventricle and will provide both pacing and defibrillation therapy.
In a dual chamber ICD, the same lead as a single chamber ICD is placed inside the right ventricle and an additional pacing lead is placed inside the right atrium.
In a CRT defibrillator system, model numbers including: DTMA1QQ, DTMA1Q1, DTMA1D4, DTMA1D1, DTMB1QQ, DTMB1Q1, DTMB1D4, DTMB1D1, DTMC1QQ, DTMC1D1, the same leads as a dual chamber ICD are placed inside the right atrium and the right ventricle and an additional pacing lead is placed into the left ventricle
Your doctor determines the best way to deliver the type of therapy needed to help relieve your heart disease symptoms.
What are the different therapies that an ICD can deliver?
Antitachycardia pacing (ATP) therapy for fast or irregular heart rhythms
During antitachycardia pacing therapy, the ICD releases several short bursts of pacing pulses. Then it pauses to check for a normal heartbeat. If the heart rhythm is still irregular, the device repeats the therapy. If the therapy restores a normal rhythm, the ICD does not deliver more treatment. If the heart rate is still too fast or irregular, the ICD delivers defibrillation therapy.
Defibrillation therapy for a fast or irregular heart rhythms
If your ICD detects a fast and unstable heart rhythm, it delivers a therapy shock to your heart. This therapy is called defibrillation. It is like the treatment provided by an external defibrillator, which uses paddles on the outside of the body to shock the heart. However, your ICD delivers much less electricity because the therapy is applied directly to the heart through the leads. The therapy shock usually stops the abnormal electrical impulses that are causing your heart to beat too fast. After each therapy shock, your ICD monitors your heart for a normal rhythm. If the rhythm is still too fast, it delivers another therapy shock. When a normal heart rhythm is restored, the device delivers no more therapy.
Pacing therapy for a slow heart rhythm
The pacing therapy performs two vital functions, pacing and sensing.
• Pacing means that the ICD sends an electrical impulse to your heart through a lead. This pacing pulse starts a heartbeat. The ICD paces the heart when the heart’s own rhythm is interrupted, irregular, or too slow.
• The ICD also senses (monitors) the heart’s natural electrical activity. When the heart device senses a natural heartbeat, it does not deliver a pacing pulse.
An ICD relieves the symptoms for most patients. However, an ICD is not a cure but rather a treatment for heart rhythm disorders. (ICD will not prevent or cure heart disease, or prevent heart attacks.)
Cardiac resynchronization therapy for an uncoordinated and irregular heart rhythm
Cardiac resynchronization therapy helps restore a normal heart rhythm by pacing both sides of the heart. CRT delivers a steady pattern of small electrical pulses to the heart muscle through the leads. These small pulses encourage the heart to beat in a regular rhythm. CRT generally stimulates the right atrium first and then both the left and right ventricles. The time between the stimulation of the right atrium and the left and right ventricles is programmed to maximize the heart’s pumping action. Because CRT paces both ventricles, the heart device controls when each side of the heart contracts. This control helps your heart maintain a normal rhythm.
What are the dimensions of the Claria™, Amplia™, Compia™ MRI SureScan™ defibrillators?
| Defibrillator Dimensions - Height x Width x Depth |
| DTMA1QQ, DTMA1Q1, DTMB1QQ, DTMB1Q1, DTMC1QQ: 74mm x 51mm x 13mm or 2.91in x 2.0 in x 0.51 in |
| DTMA1D4, DTMB1D4: 73mm x 51mm x 13mm or 2.87 in x 2.0 in x 0.51 in |
| DTMA1D1, DTMB1D1, DTMC1D1: 71mm x 51mm x 13mm or 2.79in x 2.0in x 0.51in |
| Defibrillator Weight |
| DTMA1QQ, DTMB1QQ, DTMC1QQ: 81 grams or 2.85oz |
| DTMA1Q1, DTMB1Q1: 82 grams or 2.89oz |
| DTMA1D4, DTMB1D4, DTMA1D1, DTMB1D1, DTMC1D1: 80grams or 2.82oz |
How long does the Claria™, Amplia™, Compia™ MRI SureScan™ defibrillator battery last?
CRT Models: Approximately 8.3 years
Battery longevity can vary and how long the battery lasts depends on several factors. Some of these factors include the type of pacemaker, specific programming and the nature of the heart condition.
What are some of the technology features in the Claria™, Amplia™, Compia™ MRI SureScan™ defibrillator?
The Claria™, Amplia™, Compia™ MRI SureScan™ defibrillators features the PhysioCurve design. The PhysioCurve design is tapered at the head and bottom of device to reduce skin pressure and promote patient comfort.
SmartShock™ 2.0 Technology reduces the incidence of inappropriate shocks.
When your heart cannot adjust its rate, a rate-responsive ICD uses one or more special sensors. These sensors monitor changes in your activity. Rate-responsive pacing varies its rate depending on your level of activity. The ICD uses this information to increase or decrease your heart rate. Rate-responsive pacing can be part of single chamber or dual chamber pacing.
You can undergo an MRI scan, with MRI SureScan™ technology, as long as you meet the patient eligibility requirements that Medtronic provides to your heart doctor and the scan is conducted according to Medtronic directions.
How often does the heart doctor check the defibrillator?
Your doctor will tell you how often your heart device should be checked. Your first follow-up appointment is usually scheduled for 1 month after your heart device is implanted. Depending on your doctor’s normal practice and your medical condition, additional follow-up appointments are scheduled every 3 to 6 months, either remotely or in-clinic. More frequent appointments are usually scheduled as your heart device nears its expected replacement time.
| Important Safety Information |
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Indications for Use The Claria, Amplia, Compia MRI CRT-D system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications: New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration. Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II. NYHA Functional Class I, II, or III and who have left ventricular ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post-implant. A complete SureScan CRT-D system is required for use in the MR environment. A complete SureScan CRT-D system includes the following components:
When a single coil SureScan defibrillation lead is used, a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan DF-1 defibrillation system. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com(opens new window). Any other combination may result in a hazard to the patient during an MRI scan. Lead Integrity Alert The RV Lead Integrity Alert feature is intended primarily for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data. The RV LIA feature may not perform as well with a St. Jude Medical Riata™/Durata™ lead or a Boston Scientific Endotak lead as it does when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA feature. Contraindications The Claria MRI CRT-D system is contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The device is contraindicated for patients who have a unipolar pacemaker implanted. The device is contraindicated for patients with incessant VT or VF. The device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. Warnings and Precautions Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Certain programming and device operations may not provide cardiac resynchronization. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan CRT-D system implanted in the left or right pectoral region; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On. Additionally for pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead. Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. 1.5T scanners must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating Mode or Normal Operating Mode. B1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS restriction when the isocenter is at or superior to the C7 vertebra. Continuous patient monitoring is required while MRI SureScan is programmed to On. While MRI SureScan is programmed to On, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased. Potential Complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. Potential MRI complications for the SureScan system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan is programmed to On; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer. See the MRI SureScan Technical Manual before performing an MRI Scan and Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com(opens new window) or www.mrisurescan.com(opens new window). Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. |