Contents
1 System overview ..................................................... 8
1.1 Introduction ......................................................... 8
1.2 System description .................................................. 13
1.3 Indications and usage ............................................... 16
1.4 Contraindications ................................................... 16
1.5 Pre-implant consideration ............................................ 17
2 Warnings, precautions, and potential adverse events .................. 18
2.1 General warnings and precautions .................................... 18
2.2 Explant and disposal under care ...................................... 20
2.3 Explant and disposal postmortem ..................................... 21
2.4 Handling and storage instructions ..................................... 22
2.5 Device operation .................................................... 23
2.6 Warnings, precautions, and guidance for clinicians performing medical
procedures on cardiac device patients ................................ 24
2.7 Warnings, precautions, and guidance related to electromagnetic
interference (EMI) for cardiac device patients .......................... 29
2.8 Physician training ................................................... 33
2.9 Potential adverse events ............................................. 33
2.10 Adverse events and clinical trial data ................................... 34
3 Drug information .................................................... 35
3.1 Mechanism of action ................................................ 35
3.2 Pharmacokinetics and metabolism .................................... 35
3.3 Mutagenesis, carcinogenicity, and reproductive toxicity ................... 35
4 Using the programmer ............................................... 37
4.1 Establishing telemetry between the device and the programmer ........... 37
4.2 Conducting a patient session ......................................... 41
4.3 Display screen features .............................................. 43
4.4 Enabling emergency VVI pacing ...................................... 48
4.5 Navigating a patient session with Checklist ............................. 49
4.6 Viewing and programming device parameters ........................... 51
Medtronic Micra™ MC1VR01
Clinician Manual 5
