Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
Excluding Normal Battery Depletion – This is the malfunction free survival curve.
The rate of perforation for commercially released Micra AV devices continues to perform acceptably within levels observed within the post-approval clinical study registry. Overall, predicate clinical studies for Micra VR have demonstrated a reduction in the risk of major complications of 63% through 12 months1 and 57% through 36 months2 relative to transvenous pacing systems.
EOL Indicator
From the point that the RRT is set, the pacemaker will operate for approximately six months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
6 months before battery voltage measures less than or
equal to 2.5V on 3
consecutive daily automatic
measurements.
Longevity estimates based on the following device usage.
Pace/Sense Mode VVIR
Right Ventricle Pulse Width 0.24 ms;
Lower Pace Rate 60 bpm;
Right Ventricle Percent Paced 100 %;
Upper Sensing Rate 130 ppm;
VCM Mode: Adaptive, 0.5, 1.5 Acute PSF, 0.5 PSFHide this content
1. El-Chami et al. Heart Rhythm 2018 15(12): 1800-1807.
2. Piccini et al. Heart Rhythm 2020 17(5 Supplement) D-PO02-089
* Data in these tables is sourced direct from the MDT complaint handling database summarizing observations reported to Medtronic relative to the registered US implant population.
