Menu

  • Electrophysiology
  • Therapies & Procedures
  • Patient Care Portfolio
  • Reimbursement
  • Education & Training

    • Cardiac rhythm conditions

    Discover a broad portfolio of innovative solutions to help you diagnose, treat, and manage your cardiac patients.

    Therapies and procedures

    Atrial fibrillation (AF) management

    Find out how exclusive innovations across our implantable devices and cardiac ablation portfolios can help you manage patients with or at risk of AF.

    Find out how

    Bradyarrhythmia management

    Discover a broad portfolio of bradycardia treatments that provides a range of innovative options for more of your patients.

    Discover now

    Tachyarrhythmia management

    A defibrillator isn’t just a defibrillator. Learn about our full line of implantable cardioverter defibrillator (ICD) systems for treating your patients with tachyarrhythmias.

    Learn now

    Heart failure (HF) management

    People are unique. Our cardiac resynchronization therapy (CRT) portfolio of devices is too. Our devices include a variety of comprehensive features to help tailor heart failure therapy for each of your patient’s needs.

    See the portfolio

    Cardiac diagnostics and monitoring

    Accuracy matters. Learn how our proven insertable cardiac monitors (ICMs) deliver the data you need to make the right diagnosis for your patients.1

    To view the indications, safety, and warnings, scroll down or click on one of the links below to jump you down the page to that product.

    LINQ II™ ICM ISW

    Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories

    Indications

    The LINQ II™ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

    • patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
    • patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

    Contraindications

    There are no known contraindications for the insertion of the LINQ II™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

    Warnings and precautions

    Patients with the LINQ II™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical Procedure and EMI Warnings, Precautions, and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II™ MRI technical manual.

    Accessories available for use with LINQ II™ ICM may experience connectivity or performance issues.  See product manuals for details and troubleshooting instructions.

    Potential adverse events or potential complications

    Potential adverse events from the LINQ II™ ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

    There are no known adverse events associated with the use of any LINQ II™ ICM accessory.  

    See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).

    Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.

    Brief statement for AccuRhythm™ AI ECG classification system

    Intended use

    The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

    Contraindications

    There are no known contraindications for AccuRhythm™ AI Models ZA400, ZA410, or ZA420.

    Precautions

    The AccuRhythm™ AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

    See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at (800) 328-2518.

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

    MAJ_83662

    Reveal LINQ™ ICM ISW

    Brief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessories

    Indications

    The Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

    • patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
    • patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia.

    The device has not been tested specifically for pediatric use.

    Contraindications

    There are no known contraindications for the implant of the Reveal LINQ™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

    Warnings and precautions

    Patients with the Reveal LINQ™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ™ MRI technical manual. 

    Accessories available for use with Reveal LINQ™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

    Potential adverse events or potential complications

    Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.  

    There are no known adverse events associated with the use of any Reveal LINQ™ ICM accessory.

    See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.  For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).

    Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.

    AccuRhythm™ AI ECG classification system brief statement

    Intended use

    The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

    Contraindications

    There are no known contraindications for AccuRhythm™ AI Models ZA400, ZA410, or ZA420.

    Precautions

    The AccuRhythm™ AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

    See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events.  For further information, call Medtronic Technical Services at (800) 328-2518.

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

    MAJ_83854

    AccuRhythm™ AI Algorithms ISW

    AccuRhythm AI ECG classification system brief statement

    Indications: The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

    Contraindications: There are no known contraindications for AccuRhythm AI Models ZA400, ZA410, or ZA420.

    Precautions: The AccuRhythm AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

    See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at 800-328-2518 and/or consult Medtronic’s website at medtronic.com.

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

    MAJ_84705

    Learn how

    Cardiac ablation and mapping

    Learn how catheter-based ablation may be used to treat arrhythmias.

    See how

    Patient care portfolio

    Learn about cardiac device solutions that support implant and follow-up and help keep you connected to your patients.

    Learn more

    Reduced complications

    Discover device-based innovations to reduce complications.

    63%

    reduction in major complications with the Micra™ VR transcatheter pacing system2

    81%

    reduction in LV lead dislodgements during slitting with Attain Stability™ Quad MRI SureScan™ active fixation LV lead3,4

    61%

    reduction in device pocket infections with TYRX™ absorbable antibacterial envelope5

    Reduced ER visits/hospitalizations

    Learn about exclusive device innovations to reduce ER visits and hospitalizations.

    Reduce AF-related ER visits

     

    Reduce AF-related hospitalizations

    To view the indications, safety, and warnings, scroll down or click on one of the links below to jump you down the page to that product.

    Implantable Pulse Generators (IPG) ISW

    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.

    MAJ_84705

    CRT IPGs & CRT ICDs ISW

    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 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.

    MAJ_84705

    Implantable Cardioverter Defibrillators ISW

    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.

    MRI Conditions for Use

    Medtronic SureScan ICD systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use.  Patients with MRI SureScan ICDs may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When SureScan systems are 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 system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. 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/.  Any other combination may result in a hazard to the patient during an MRI scan.

    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.

    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 and the system must be implanted in the left or right pectoral region.

    Potential adverse events

    Potential adverse events include, but are not limited to, body rejection phenomena, device migration, erosion through the skin, muscle and/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. 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 MRI SureScan Technical Manual before performing an MRI Scan.

    See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or http://www.mrisurescan.com/.

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

    MAJ_84705

    Reduce HF readmissions

    To view the indications, safety, and warnings, scroll down or click on one of the links below to jump you down the page to that product.

    Implantable Pulse Generators (IPG) ISW

    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.

    MAJ_84705

    CRT IPGs & CRT ICDs ISW

    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 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.

    MAJ_84705

    Implantable Cardioverter Defibrillators ISW

    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.

    MRI Conditions for Use

    Medtronic SureScan ICD systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use.  Patients with MRI SureScan ICDs may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When SureScan systems are 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 system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. 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/.  Any other combination may result in a hazard to the patient during an MRI scan.

    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.

    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 and the system must be implanted in the left or right pectoral region.

    Potential adverse events

    Potential adverse events include, but are not limited to, body rejection phenomena, device migration, erosion through the skin, muscle and/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. 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 MRI SureScan Technical Manual before performing an MRI Scan.

    See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or http://www.mrisurescan.com/.

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

    MAJ_84705

    • Automatically identify patients at the highest risk of heart failure hospitalization in the next 30 days with TriageHF™ technology, a heart failure risk stratification tool.9

    Additional resources

    Medtronic 24-hour support

    Phone: 800-505-4636

    Follow us on social media.

    Stay up to date on product updates and events. 

    Products

    Filter by
    1. ICM publications. Medtronic data on file. 2021.
    2. El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018;15(12):1800–1807. doi: 10.1016/j.hrthm.2018.08.005.
    3. Crossley GH, Biffi M, Johnson B, et al. Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study. Heart Rhythm. 2015;12(4):751–758. doi: 10.1016/j.hrthm.2014.12.019.
    4. Crossley GH, et al. Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy. Presented at HRS 2019.
    5. Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med. 2019;380(20):1895–1905. doi: 10.1056/NEJMoa1901111.
    6. Boriani G, Manolis AS, Tukkie R, et al. Effects of enhanced pacing modalities on health care resource utilization and costs in bradycardia patients: An analysis of the randomized MINERVA trial. Heart Rhythm. 2015;12(6):1192–1200. doi: 10.1016/j.hrthm.2015.02.017.
    7. Lemke B, et al. Atrial fibrillation resource use with an adaptive device algorithm. Presented at CardioStim 2014.
    8. Starling RC, Krum H, Bril S, et al. Impact of a novel adaptive optimization algorithm on 30-day readmissions: evidence from the adaptive CRT trial. JACC Heart Fail. 2015;3(7):565–572. doi: 10.1016/j.jchf.2015.03.001.
    9. Cowie MR, Sarkar S, Koehler J, et al. Development and validation of an integrated diagnostic algorithm derived from parameters monitored in implantable devices for identifying patients at risk for heart failure hospitalization in an ambulatory setting. Eur Heart J. 2013;34(31):2472–2480. doi: 10.1093/eurheartj/eht083.