Indications, safety, and warnings Micra™ VR2 leadless pacemaker

Indications (or intended use)

Micra VR2 Model MC2VR01 is indicated for use in patients who have experienced one or more of the following conditions:

• paroxysmal or permanent high-grade AV block in the presence of AF
• 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
• 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

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 VR2 Model MC2VR01 is contraindicated for patients who have the following types of medical devices implanted:

• an implanted device that would interfere with the implant of the Micra VR2 device in the judgment of the implanting physician
• an implanted inferior vena cava filter and if jugular venous anatomy is unable to accommodate a 7.8 mm (23 Fr) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity).
• a mechanical tricuspid valve
• an implanted cardiac device providing active cardiac therapy that may interfere with the sensing performance of the Micra VR2 device

The device is contraindicated for patients who have the following conditions:

• venous anatomy unable to accommodate a 7.8 mm (23 Fr) 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)
• known intolerance to the materials listed in the Instructions for Use or to heparin, or sensitivity to contrast media that cannot be adequately premedicated

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. 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.

Potential adverse events or potential complications

Potential complications include, but are not limited to, toxic/allergic reaction, oversensing, pacemaker syndrome, cardiac arrest, necrosis, 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 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.