Medtronic Cobalt and Crome™ MRI SureScan™ Defibrillators and CRTDs


Medtronic Cobalt and Crome™ MRI SureScan™ Defibrillators and CRTDs

Model Numbers: DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ, DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ, DTPC2D1, DTPC2D4, DTPC2Q1, DTPC2QQ, DDPA2D1, DDPA2D4, DDPB3D1, DDPB3D4, DDPC3D1, DDPC3D4, DVPA2D1, DVPA2D4, DVPB3D1, DVPB3D4, DVPC3D1, DVPC3D4

Table of Contents

 

How does an implantable cardioverter defibrillator (ICD) or 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. 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 Cobalt and Crome™ MRI SureScan™ defibrillator and CRTD systems?

For a single chamber ICD, model numbers including: DVPA2D1, DVPA2D4 , DVPB3D1, DVPB3D4, DVPC3D1 and DVPC3D4 a single lead is placed inside the right ventricle and will provide both pacing and defibrillation therapy. 

In a dual chamber ICD, model numbers including: DDPA2D1, DDPA2D4, DDPB3D1, DDPB3D4, DDPC3D1 and DDPC3D4 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: DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ, DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ, DTPC2D1, DTPC2D4, DTPC2Q1 and DTPC2QQ 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.

Cardiac resynchronization therapy for an uncoordinated and irregular heart rhythm

Cardiac resynchronization therapy (only available in CRT defibrillator systems) 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.

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.)

 

What are the dimensions of the Cobalt and Crome™ MRI SureScan™ defibrillators and CRTDs?

   

 

Device Dimensions - Height x Width x Depth
DTPB2QQ, DTPB2Q1, DTPA2Q1, DTPA2QQ, DTPC2Q1 and DTPC2QQ: 74 mm x 51 mm x 13 mm
DTPB2D4, DTPA2D4 and DTPC2D4: 73 mm x 51 mm x 13 mm or 2.87 in x 2.0 in x 0.51 in
DTPB2D1, DTPA2D1 and DTPC2D1: 71 mm x 51 mm x 13 mm or 2.8 in x 2.0 in x 0.51 in
DDPA2D4, DDPB3D4 and DDPC3D4: 68 mm x 51 mm x 13 mm or 2.68 in x 2.0 in x 0.51 in
DVPA2D1, DVPB3D1, DDPA2D1, DDPB3D1, DVPC3D1 and DDPC3D1: 66 mm x 51 mm x 13 mm or 2.6 in x 2.0 in x 0.51 in
DVPA2D4, DVPB3D4 and DVPC3D4: 64 mm x 51 mm x 13 mm or 2.52 in x 2.0 in x 0.51 in
Device Weight 
DTPB2QQ, DTPB2Q1, DTPA2Q1, DTPA2QQ, DTPC2Q1 and DTPC2QQ: 83 g or 2.93 oz
DTPB2D4, DTPA2D4 and DTPC2D4: 82.1 g or 2.9 oz
DTPB2D1, DTPA2D1 and DTPC2D1: 82 g or 2.89 oz
DDPA2D4, DDPB3D4 and DDPC3D4: 80 g or 2.82 oz
DVPA2D1, DVPB3D1, DDPA2D1, DDPB3D1, DVPA2D4, DVPB3D4, DVPC3D4, DVPC3D1 and DDPC3D1: 79 g or 2.79 oz

How long does the Cobalt and Crome™ MRI SureScan™ defibrillator battery last?

CRTD Models: Approximately 9.5-10.1years
DR Models: Approximately 11.9 years
SR Models:  Approximately 13.6 years

Battery longevity can vary and how long the battery lasts depends on several factors. Some of these factors include the type of defibrillator, specific programming and the nature of the heart condition. 

What are some of the technology features in the Cobalt and Crome™ MRI SureScan™ defibrillators and CRTDs?

Cobalt and Crome™ MRI SureScan™ defibrillators and CRTDs feature the PhysioCurve design.  The PhysioCurve design is tapered at the head and bottom of device to reduce skin pressure and promote patient comfort.

Cobalt and Crome™ MRI SureScan™ defibrillators and CRTDs uses BlueSync™ technology which enables secure, wireless communication and remote monitoring with your heart doctor.

SmartShock™ 2.0 Technology reduces the incidence of inappropriate shocks.

When your heart cannot adjust its rate, a rate-responsive pacemaker 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 pacemaker 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 within the first 3 months after your heart device is implanted. Depending on your doctor’s advice and your medical condition, additional follow-up appointments are scheduled every 3 to 6 months. As your heart device gets close to its replacement time, you usually have more appointments.

 

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Important Safety Information

INDICATIONS

The Cobalt™ XT, Cobalt™, and Crome™ HF CRT-D MRI SureScan™ systems are indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions:

  • NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical therapy and have LVEF ≤ 35% and a prolonged QRS duration
  • NYHA Functional Class II patients who have left bundle-branch block (LBBB) with a QRS duration ≥ 130 ms and a left ventricular ejection fraction ≤ 30%
  • NYHA Functional Class I, II, or III who are on stable, optimal medical therapy (if indicated), and have LVEF ≤ 50%,atrioventricular block (AV block), and are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing

The Cobalt XT, Cobalt, and Crome VR and DR ICD MRI SureScan systems are indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.

MRI Conditions for Use: Medtronic SureScan ICD and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. ICD and CRT-D SureScan system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan defibrillation system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.

CONTRAINDICATIONS

The Cobalt XT, Cobalt, and Crome VR and DR ICD and CRT-D MRI SureScan systems are contraindicated for use in the following situations:

  • If implanted with a unipolar pacemaker.
  • If incessant VT or VF exists.
  • If the primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.
  • If tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, and sepsis.

WARNINGS AND PRECAUTIONS

Changes in a 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. Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history. The device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region.

POTENTIAL ADVERSE EVENTS OR POTENTIAL COMPLICATIONS

Potential adverse events include, but are not limited to, the following events: allergic reactions, atrial fibrillation, bradyarrhythmia, cardiac arrest, device migration, discomfort, dizziness, dyspnea, erosion, excessive fibrotic tissue growth, heart failure or loss of CRT (for CRT-D patients), hematoma, hemorrhage, inability to deliver therapy, inappropriate shock, infection, lead migration/dislodgement, lethargy, loss of pacing, mental anguish, necrosis, nerve damage, oversensing, palpitations, seroma, syncope, tachyarrhythmia, tissue damage due to heating of the device, undersensing, and wound dehiscence. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, spontaneous tachyarrhythmia, potential for VT/VF induction, device heating that results in tissue damage, stimulation of the leads that results in continuous capture, VT/VF, hemodynamic collapse, damage to the device or the leads, causing the system to fail or treat the patient’s condition incorrectly, and movement or vibration of the device or the leads, resulting in dislodgement.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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