PACING THERAPY
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See the 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 Medtronic’s website at www.medtronic.com.
Brief Statement: IPGs
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. 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. For the MR Conditional IPGs, a complete SureScan® pacing system, which consists of an approved combination (see http://www.mrisurescan.com/) MRI SureScan device with SureScan lead(s), is required for use in the MR environment.
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. Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway.
Warnings/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.
For MR Conditional IPG Systems, before performing an MRI scan, refer to the SureScan pacing system technical manual for additional information, patients and their implanted systems must be screened to meet the MRI Conditions of Use. Do not scan patients who do not have a complete SureScan pacing system consisting of an approved combination MRI SureScan device with SureScan lead(s); patients who have broken, abandoned or intermittent leads; or patients who have a lead impedance value of < 200 Ω or > 1,500 Ω.
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.
SureScan 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 induced currents 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. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Brief Statement: Azure™ MRI SureScan™ SR and DR IPG
Indications
The Azure DR MRI and Azure SR MRI SureScan systems are indicated for the rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Accepted patient conditions warranting chronic cardiac pacing include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, or bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.
The Azure DR MRI devices 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, VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.
MRI Conditions for Use:
Medtronic SureScan pacing systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Pacemaker 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 pacing 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 http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.
Contraindications
The Azure DR MRI and Azure SR MRI SureScan systems are contraindicated for concomitant implantation with another bradycardia device or with an implantable cardioverter defibrillator. 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. ATP therapy is contraindicated in patients with an accessory antegrade pathway.
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. 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 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 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, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. 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 induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.
See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications. For further information, call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com .
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Combined Micra™ and Micra AV™ Brief Statement
Indications
Micra devices, Micra Model MC1VR01 and Micra AV Model MC1AVR1, are indicated for use in patients who have experienced one or more of the following conditions:
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Paroxysmal or permanent high-grade AV block in the presence of AF
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Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when a dual-chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy
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Symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when a dual-chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy
Micra AV Model MC1AVR1 is also indicated for VDD pacing in patients with adequate sinus rates who may benefit from maintenance of AV synchrony. The Micra AV device provides AV synchronous ventricular pacing similar to a transvenous VDD system. The implanted device depends on the appropriate sensing of atrial mechanical signals to achieve AV synchrony. The level of AV synchrony may vary in individual patients and may not be predictable prior to implant.
Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.
The device is designed to be used only in the right ventricle.
Contraindications
Micra Model MC1VR01 and Micra AV Model MC1AVR1 are contraindicated for patients who have the following types of medical devices implanted: an implanted device that would interfere with the implant of the Micra device in the judgment of the implanting physician, an implanted inferior vena cava filter, a mechanical tricuspid valve, or an implanted cardiac device providing active cardiac therapy that may interfere with the sensing performance of the Micra device.
The device is contraindicated for patients who have the following conditions: femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity), morbid obesity that prevents the implanted device from obtaining telemetry communication within ≤12.5 cm (4.9 in), or known intolerance to the materials listed in the Instruction for Use, or to heparin, or sensitivity to contrast media that cannot be adequately premedicated, or if the steroid dose from this device cannot be tolerated.
Warnings and Precautions
End of Service (EOS) – When the EOS condition is met, the clinician has the option of permanently programming the device to Off and leaving it in the heart, or retrieving the device, provided the device has not yet become encapsulated. Removal of the Micra device after it has become encapsulated may be difficult because of the development of fibrotic tissue. If removal of the device is required, it is recommended that the removal be performed by a clinician who has expertise in the removal of implanted leads.
MRI conditions for use – Before an MRI scan is performed on a patient implanted with the Micra device, the cardiology and radiology professionals involved in this procedure must understand the requirements specific to their tasks as defined in the device manuals.
Rate-responsive mode may not be appropriate for patients who cannot tolerate pacing rates above the programmed Lower Rate. For Micra Model MC1VR01, asynchronous VVIR pacing with sinus rhythm may not be appropriate when competitive pacing is considered undesirable or causes symptoms of pacemaker syndrome. The patient’s age and medical condition should be considered by physicians and patients as they select the pacing system, mode of operation, and implant technique best suited to the individual.
Precautions should be taken before administering anticoagulant agents, antiplatelet agents, or contrast media in patients with known hypersensitivity to these agents.
The use of deactivated Micra devices in situ and an active Micra device, or an active transvenous pacemaker or defibrillator, has not been clinically tested to determine whether EMI or physical interaction is clinically significant. Bench testing supports that implantation of an active Micra device, or an active transvenous pacemaker or defibrillator, next to an inactivated Micra device is unlikely to cause EMI or physical interaction. Post-approval studies are planned to characterize risks of co-implanted, deactivated Micra devices. Currently recommended end of device life care for a Micra device may include the addition of a replacement device with or without explanation of the Micra device, which should be turned off.
For Micra AV Model MC1AVR1, patient activities and environments which present mechanical vibrations to the patient can interfere with the mechanical sensing of atrial contractions. This can result in a loss of AV synchrony.
Potential Complications
Potential complications include, but are not limited to, toxic/allergic reaction, oversensing, pacemaker syndrome, cardiac arrest, acceleration of tachycardia, necrosis, myocardial infarction and surgical complications such as cardiac perforation, pericardial effusion, cardiac tamponade, device embolization, hematoma, AV fistula, vessel dissection, infection, cardiac inflammation, and thrombosis.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, MRI conditions for use, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Brief Statement: Transvenous SureScan™ Pacing Systems
Indications
Contraindications
Potential Complications
Brief Statement: CapSureFix MRI™ SureScan™ Lead Models 5076 and 5086MRI
Indications
Contraindications
Warnings/Precautions
Potential Complications
General Right Heart MRI SureScan Pacing and Sensing Lead Brief Statement
Indications
Medtronic leads have application where implantable atrial and/or ventricular, single or dual chamber pacing systems are indicated. Leads are intended for pacing and sensing in the right atrium and/or ventricle. MRI SureScan™ leads (which include specified lengths of Models 5076, 4076, 4074, 4574, 5086MRI and 3830; consult individual lead model technical manuals for more detail) are indicated for use as a system consisting of an indicated Medtronic MRI SureScan device, implanted with SureScan leads. A complete system is required for use in the MRI environment.
Contraindications
Warnings and Precautions
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. Some lead models allow the use of therapeutic ultrasound; consult individual lead model technical manuals for more detail.
For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied.
Do not use magnetic resonance imaging (MRI) on patients who have non-MR conditional versions/lengths of these leads implanted as part of a complete SureScan System. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.
MRI SureScan Leads only: A complete SureScan pacing or 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.
Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging.
Potential Complications
Potential patient-related complications related to the use of transvenous leads include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential lead-related complications may include exit block, lead dislodgement, lead fracture, insulation failure, and threshold elevation.
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 induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.
See the appropriate Device MRI SureScan Technical Manual before performing an MRI Scan and Lead Technical 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 Medtronic’s website at www.medtronic.com or www.mrisurescan.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Brief Statement: Medtronic Leads
Indications
Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are intended for pacing and sensing and/or defibrillation. Defibrillation leads have application for patients for whom implantable cardioverter defibrillation is indicated
Contraindications
Medtronic leads are contraindicated for the following:
- ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
- patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone acetate may be contraindicated. (includes all leads which contain these steroids)
- Epicardial leads should not be used on patients with a heavily infarcted or fibrotic myocardium.
The SelectSecure Model 3830 Lead is also contraindicated for the following:
- patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated.
- patients with obstructed or inadequate vasculature for intravenous catheterization.
Warnings/Precautions
People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.
For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied.
Potential Complications
Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation or exit block.
See the 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 Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
C315 Catheter Brief Statement
Indications (or Intended Use)
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Contraindications
Use of the C315 percutaneous catheter is contraindicated in patients with obstructed or inadequate vasculature.
Warnings and Precautions
- This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.
- Keep external defibrillation equipment nearby for immediate use during insertion, placement, acute lead system testing, or whenever arrhythmias are possible or intentionally induced. Backup pacing should be readily available during implant. Use of a delivery system and/or leads may cause heart block. For further information about this and other potential adverse events or complications, refer to the technical manual packaged with the appropriate product.
- Use care when passing a catheter through vessels and tissue. Avoid damage, such as perforations and dissections, to vessels and cardiac tissue, during catheter passage and positioning. Do not push, pull, or rotate the catheter against resistance. If resistance is met, discontinue movement, determine the reason for resistance, and take appropriate action before continuing. Damage to the catheter may prevent it from performing with accurate torque response and control, and may cause vessel damage.
- Use the catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of any non-Medtronic device with the catheter. Consequences of using the catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device or catheter during delivery. Slitting evaluations on this product were conducted using Medtronic Universal II or Medtronic Adjustable Slitters. These are the only slitters recommended for use with the C315 catheter.
- Handle the catheter with care at all times. Do not kink, stretch, or severely bend the catheter. Do not use surgical instruments to grasp the catheter. Do not use excessive force when inserting a catheter into a vessel. Ensure the catheter is thoroughly flushed and free of air prior to use. Avoid contact with liquids other than blood, saline, or contrast solution. Use in conjunction with fluoroscopic guidance and proper anticoagulation agents.
- Use the side port on the hub to flush the catheter. The catheter must be thoroughly flushed and free of air prior to use. When using the side port, consider sealing the proximal opening of the hemostatic valve with a thumb or forefinger.
Potential Adverse Events or Potential Complications
Air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.
See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
C304 SelectSiteTM Catheter Brief Statement
Indications (or Intended Use)
The device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left
heart via the coronary sinus.
Contraindications
Use of the device is contraindicated for patients with obstructed or inadequate vasculature and for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.
Warnings and Precautions
- The device is for single use only and is not intended to be resterilized.
- Use the deflectable catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of the deflectable catheter with any device not manufactured by Medtronic. For the C304 Catheters, no test data is available to demonstrate compatibility of the transvenous devices with an outer diameter larger that 1.5mm (4.6Fr), with the exception of the 1.85mm (5.6Fr) dilator included with the device package. Consequences of using the deflectable catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.
- Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product.
- Handle the deflectable catheter with care at all times. Do not kink, stretch, or severely bend the deflectable catheter. Do not use surgical instruments to grasp the deflectable catheter. Avoid contact with liquids other than isopropyl alcohol, blood, saline, or contrast solution.
- Use the valve to impede the back flow of venous blood during the implant procedure. Ensure that the flush port stopcock is closed before attaching the valve to the deflectable catheter hub.
- Keep external defibrillation and backup pacing readily available during implant. Use of the device, transvenous devices, or both may cause heart block.
Potential Adverse Events or Potential Complications
Potential adverse events related to the use of the deflectable catheter may include, but are not limited to, the following events: air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.
See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.