Indications, Safety, and Warnings Cardiac Device Features

Brief Statement: Medtronic IPGs

Brief Statement: CRT IPGs and CRT ICDs

Brief Statement: ICDs

BRIEF STATEMENT: MEDTRONIC IPG

INDICATIONS

Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and increases in activity. Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. See device manuals for the accepted patient conditions warranting chronic cardiac pacing. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in patients with one or more of the above pacing indications.

MRI SureScan IPGs: A complete SureScan pacing system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads.

CONTRAINDICATIONS

IPGs are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient's age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Antitachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway. Medtronic Kappa^™ 400 Series pacemakers are contraindicated for use with epicardial leads and with abdominal implantation.

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.

MRI SureScan IPGs only: 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.  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.  Patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on must have no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms.  It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks).  Pace polarity parameters are set to Bipolar for programming MRI SureScan to On (Advisa MRI only); or a SureScan pacing system is implanted with a lead impedance value of ≥ 200 Ω and ≤ 1500 Ω.  Revo MRI patients must have pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms and a SureScan pacing system that has been implanted for a minimum of 6 weeks.

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 arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

MRI SureScan IPGs: SureScan pacing systems have been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse. 

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. See the appropriate product MRI SureScan Technical Manual before performing an MRI Scan. For further information, please call Medtronic at 1-800-328-2518 and/or consult www.medtronic.com or www.mrisurescan.com.

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

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BRIEF STATEMENT: Medtronic CRT IPG AND CRT ICD

INDICATIONS

CRT-Ps are indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35% and a prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50%, are on stable, optimal heart failure medical therapy if indicated and have 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. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in patients with one or more of the above pacing indications.

CRT-Ds are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias 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. Some CRT-Ds are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias. The RV Lead Integrity Alert (LIA) feature is intended primarily for patients who have a Medtronic 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 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.

A complete SureScan system is required for use in the MR environment.

Contraindications

CRT-Ps are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway.

CRT-Ds are contraindicated in 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; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.

Warnings and Precautions

A complete SureScan system is required for use in the MR environment. Before performing an MRI scan, refer to the CRT-P or CRT-D MRI SureScan Technical Manual for  MRI-specific warnings and precautions. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for the right atrial port. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. For a CRT-D SureScan system, 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 defibrillation system. Any other combination may result in a hazard to the patient during an MRI scan.

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.

Certain programming and device operations may not provide cardiac resynchronization. Also for CRT-Ps, Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may experience loss of cardiac resynchronization therapy and/or loss of AV synchrony. For this reason, the device should be replaced prior to ERI being set. Use of the device should not change the application of established anticoagulation protocols.

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 system implanted in the left or right pectoral region. Additionally, for patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On, no diaphragmatic stimulation is present at a pacing output of 5.0 V and at a pulse width of 1.0 ms. 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. 

Potential Adverse Events

Potential adverse events include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional complication for CRT-Ds is the acceleration of ventricular tachycardia.

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 MRI 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 CRT-P or CRT-D MRI SureScan Technical Manual before performing an MRI Scan.

See the appropriate CRT-P or CRT-D Device Manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. See the appropriate CRT-P or CRT-D MRI SureScan Technical Manual before performing an MRI Scan. For further information, call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.

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

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BRIEF STATEMENT: Medtronic ICD

INDICATIONS

Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Some ICDs are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.

Additional notes for DR ICDs: The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to be 18.2% in the AF-only patient population studied.

The RV Lead Integrity Alert (LIA) 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.

MRI SureScan ICDs: A complete SureScan defibrillation system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads.

CONTRAINDICATIONS

ICDs are contraindicated in 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; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.

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.

MRI SureScan ICDs only: A complete SureScan defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI Technical Manual for MRI-specific warnings and precautions. 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 defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; 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.

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 arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional complication for ICDs is the acceleration of ventricular tachycardia.

MRI SureScan ICDs: SureScan defibrillation systems have been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. See the MRI SureScan System Technical Manual before performing an MRI Scan. For further information, please call Medtronic at 1-800-328-2518 and/or consult www.medtronic.com or www.mrisurescan.com.

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