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

Device Survival Probability

MC1VR01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 65.0 mo        
% Excluding Normal Battery Depletion 99.9 99.8 99.6 99.5 99.2 99.2        
% Including Normal Battery Depletion 99.8 99.6 99.1 98.4 97.2 96.5        
#   16544 7494 2422 401 168 114        
  • 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.
Information

Product Characteristics

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

CareLink Population

Enrolled 25500
Active 21292
Cumulative Follow-Up Months 450673
Normal Battery Depletion 48
Information 45

CareLink Qualifying Malfunctions/Complications

Cardiac Perforation 6
Dislodgements 1
Elevated Pacing Threshold 27
Failure to Capture 3
Premature Battery Depletion 8
Information

Distribution Data

US Market Release2016-04-06
CE Approval Date2015-04-14
Registered USA Implants49780
US Market Release2016-04-06
CE Approval Date2015-04-14
Estimated WW Distribution103380
Information

*Acute Observations (N = 49780)

Cardiac Perforation12
Dislodgement12
Elevated Pacing Threshold116
Failure to Capture40
Failure to Sense7
Information

*Day of Implant Observations (N = 49780)

Cardiac Perforation193
Dislodgement99
Elevated Pacing Threshold167
Failure to Capture69
Failure to Sense50
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.
Information

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.

Information

Recommended Replacement (RRT)

6 months before battery voltage measures less than or equal to 2.5V on 3 consecutive daily automatic measurements.

Information

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
Footnote

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 October 11, 2021

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