MC1AVR1 Micra AV
Transcatheter Pacing System (TPS)
MC1AVR1 Micra AV
Information

Device Survival Probability

MC1AVR1_SURV
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    1 yr at 19.0 mo                
% Excluding Normal Battery Depletion 99.8 99.8                
% Including Normal Battery Depletion 99.7 99.7                
#   1927 106                
  • 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

Customer Communications For This Model

Information

Product Characteristics

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

CareLink Population

Enrolled 8655
Active 8301
Cumulative Follow-Up Months 65827
Normal Battery Depletion 3
Information 9

CareLink Qualifying Malfunctions/Complications

Dislodgements 1
Elevated Pacing Threshold 5
Failure to Capture 3
Information

Distribution Data

US Market Release2020-01-15
CE Approval Date2020-03-31
Registered USA Implants18733
US Market Release2020-01-15
CE Approval Date2020-03-31
Estimated WW Distribution26246
Information

*Acute Observations (N = 18733)

Cardiac Perforation6
Dislodgement9
Elevated Pacing Threshold25
Failure to Capture11
Failure to Sense59
Information

*Day of Implant Observations (N = 18733)

Cardiac Perforation123
Dislodgement26
Elevated Pacing Threshold51
Failure to Capture33
Failure to Sense15

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.

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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 12.1 12.8
Nominal 2.0 V 7.8 9.1
High 2.5 V 6.4 7.6
Footnote

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.

Data as of December 16, 2021

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