Pacemakers

Micra™ VR2 leadless pacemaker

<p>Micra™ VR2 provides an unmatched leadless pacing experience for patients with bradycardia.</p>

Indications, Safety, and WarningsIndications (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.ContraindicationsMicra™ VR2 Model MC2VR01 is contraindicated for patients who have the following types of medical devices implanted:

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 precautionsEnd 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 complicationsPotential 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.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83886