MC1VR01 Micra VR
Transcatheter Pacing System (TPS)
MC1VR01 Micra VR

Device Survival Probability


    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr        
% Excluding Normal Battery Depletion 99.9 99.8 99.8 99.7 99.6 99.6        
% Including Normal Battery Depletion 99.8 99.7 99.2 98.6 97.3 93.9        
#   26777 14974 9926 4349 1241 148        
  • 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.

Product Characteristics

Generator Type TPS
Max. Delivered Energy N/A
Serial Number Prefix MCR
Mass 1.75 g
Volume 1 cc
Waveform N/A
X-Ray ID Medtronic Logo
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CareLink Population

Enrolled 35749
Active 25644
Cumulative Follow-Up Months 891607
Normal Battery Depletion 159
Information 62

CareLink Qualifying Malfunctions/Complications

Cardiac Perforation 7
Dislodgements 2
Elevated Pacing Threshold 36
Failure to Capture 7
Premature Battery Depletion 10

Distribution Data

US Market Release2016-04-06
CE Approval Date2015-04-14
Registered USA Implants66212
US Market Release2016-04-06
CE Approval Date2015-04-14
Estimated WW Distribution141756

*Acute Observations (N = 66212)

Cardiac Perforation20
Elevated Pacing Threshold146
Failure to Capture71
Failure to Sense12

*Day of Implant Observations (N = 66212)

Cardiac Perforation271
Elevated Pacing Threshold235
Failure to Capture108
Failure to Sense69
The rate of perforation for commercially released Micra VR devices continues to perform acceptably within levels observed within the post-approval clinical study registry. Overall, clinical studies 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.


Estimated Longevity

Amplitude Setting 500 Lead Ω 700 Lead Ω
Low 1.0 V 12.17 12.8
Nominal 2.0 V 7.9 9.1
High 2.5 V 6.5 7.6

Longevity estimates based on the following device usage. Pace/Sense Mode VVI 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 , 1.0 PSF Hide 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.

Data as of May 10, 2023 926050