PRODUCT SPECIFICATIONS
Physical characteristics
Volume 0.8 cc
Length 25.9 mm
Outer diameter 6.7 mm (20.1 Fr)
Mass 1.75 g
Materials in chronic contact
with human tissue
a
Titanium, titanium nitride,
parylene C, primer for
parylene C, PEEK, siloxane,
nitinol, platinum, iridium, liquid
silicone rubber, and silicone
medical adhesive
Steroid Dexamethasone acetate,
< 1.0 mg, MCRD release
mechanism
Fixation mechanism Nitinol FlexFix™ Tines
Nominal pacing cathode 2.5 mm
2
, Pt sintered,
TiN coated
Minimum pacing anode 22 mm
2
, TiN coated
Cathode to anode spacing 18 mm
a
These materials have been successfully tested for the ability to avoid biological
incompatibility. The device does not produce an injurious temperature in the
surrounding tissue during normal operation.
Battery characteristics
Manufacturer
Medtronic Energy and
Component Center
Model M957651A001
Chemistry
Lithium-hybrid CFx silver
vanadium oxide
Initial voltage 3.2 V
Mean usable capacity 120 mAh
Estimated time from
RRT to EOS
6 months (180 days)
Replacement indicators
Recommended Replacement
Time (RRT)
6 months (180 days)
before EOS
Elective Replacement
Indicator (ERI)
3 months (90 days) after RRT
End of Service (EOS)
≤ 2.5 V on 3 consecutive daily
automatic measurements
§ Dual Chamber (VDD)
§ SureScan
™
Technology
Micra
™
AV
Transcatheter Pacing System
MC1AVR1
Longevity
Projected service life in years*
Pacing Amplitude Pacing
Rate
Impedance Predicted
Service Life
Pulse width
0.24 ms
Pulse width
0.4 ms
VDD, 0% 1.5 V 60 bpm 500 ohms 15.1 15.1
VDD, 5% 1.0 V
1.5 V
2.0 V
60 bpm
60 bpm
60 bpm
500 ohms
500 ohms
500 ohms
14.8
14.6
14.3
14.7
14.4
14.0
VDD, 50% 1.0 V
1.5 V
2.0 V
60 bpm
60 bpm
60 bpm
500 ohms
500 ohms
500 ohms
11.9
10.8
9.5
11.2
9.7
8.1
VDD,
100%
1.0 V
1.5 V
2.0 V
2.5 V
60 bpm
60 bpm
60 bpm
60 bpm
500 ohms
500 ohms
500 ohms
500 ohms
10.2
8.6
6.9
5.8
9.2
7.3
5.4
4.3
VDD,
100%
1.5 V
1.5 V
60 bpm
60 bpm
400 ohms
600 ohms
8.1
9.0
6.7
7.7
VDD,
100%
1.5 V
1.5 V
70 bpm
100 bpm
500 ohms
500 ohms
8.0
6.8
6.7
5.5
VDD,
100%
2.5 V
3.5 V
5.0 V
60 bpm
60 bpm
60 bpm
600 ohms
500 ohms
500 ohms
6.3
3.7
2.0
4.8
2.5
1.4
*Projected service life estimates are based on accelerated battery discharge data and
device modeling as specified. Do not interpret these values as precise numbers.
Note: The longevity projections are based on typical shelf storage time.
Assuming worst-case shelf storage time (18 months), longevity is reduced by
approximately 5.8%.
Stored data and diagnostics
Battery and device measurement data
The device automatically and continuously monitors its
battery, pacing, and sensing performance throughout the
life of the device. You can view the following data on the
programmer screens and print reports:
Battery and Device Measurements: Battery Voltage,
Remaining Longevity, Sensing Integrity Counter, Electrode
Impedance, Capture Threshold, Sensing Electrode
Impedance Trend, Capture Threshold Trend, R-Wave
Amplitude Trend, A4 Amplitude Trend, Rate Histogram
(Ventricular, Atrial Ventricular)
Device performance trend data
The device stores the daily measurements for 15 days.
After 15 days, the device stores the weekly high and low
measurements up to 80 weeks. Beyond 80 weeks, the data
is maintained on a first collected, first-deleted basis.
Electrode Impedance Trend, Capture Threshold Trend,
R-Wave Amplitude Trend, A4 Amplitude Trend
Rate Histogram data
Rate histogram data is available to view on the programmer
and print as a printed report. The Rate histogram data
shows the percent of total time for atrial mechanical
sensed-ventricular paced (AM-VP) events, atrial mechanical
sensed-ventricular sensed (AM-VS) events, ventricular
sensed (VS) only events, and ventricular paced (VP) only
events. This data also shows the distribution of AM-VP
events, AM-VS events, VS only events, and VP only events
recorded since the last patient session.
Device parameters
Emergency VVI settings
Parameter Selectable values
Mode VVI
Lower Rate 70 bpm
Sensitivity 2.0 mV
Amplitude 5 V
Pulse Width 1 ms
Blank Post VP 240 ms
Blank Post VS 120 ms
Rate Hysteresis Off
Pacing parameters
Modes, rate, and intervals
Parameter Programmable values
Mode
VDD
; VDI; VVIR; VVI; VOO;
ODO; OVO; Device Off
Lower Rate
a,b,c
30; 35; 40 … 50 55; 60; 70;
75; 80; 90 … 170 bpm
Upper Tracking Rate
80; 90; 95; 100; 105
; 110;
115 bpm
Activity Mode Switch On
; Off
AV Conduction Mode Switch On ; Off
a
The corresponding pulse interval can be calculated as follows: pulse interval
(ms) = 60,000/Lower Rate.
b
The escape interval is within –10/+25 ms of the programmed rate, measured
in accordance with ISO 14708-2:2012 (Clause 6.1.5).
c
Programmable values for Lower Rate do not include 65 bpm.
Atrial parameters
Parameter Programmable values
A. Sensing Vector 1; 2; 3; 1+2
; 1+3; 2+3; 1+2+3
Live Waveform Display
Rectified
; Vector 1 Source;
Vector 2 Source; Vector 3
Source
A3 Threshold
1.0; 1.2; 1.4 … 4.0 ; 4.5; 5.0 …
10.0; Max m/s
2
Auto On ; Off
A3 Window End 600; 625 … 775
… 1,000 ms
Auto On ; Off
Min Auto A3 Window End 600; 625 … 750
; 775; 800 ms
Max Auto A3 Window End 650; 675 … 900
; 925 … 1,000 ms
A4 Threshold
a
0.7; 0.8; 0.9; 1.0; 1.2 ; 1.4 … 3.0;
3.5; 4.0 … 8.0 m/s
2
Auto On ; Off
Min Auto A4 Auto Threshold
0.7; 0.8
; 0.9; 1.0; 1.2; 1.4;
1.6 m/s
2
Sensed AV (AM-VP) 20 ; 30 … 200 ms
PVAB 450; 500; 550
; 600 ms
PVARP Auto
; 500; 550 … 750 ms
Max PVARP 500; 550; 600
… 750 ms
Rate Smoothing On
; Off
Smoothing Delta 50; 100
; 150; 200 ms
Tracking Check
b
On ; Off
Tracking Check Rate 90; 100
; 110 bpm
Atrial Sensing Setup
c
On/Restart; Off/Complete
a
The range of values for this parameter can also be considered the atrial
sensitivity range for the device.
b
Tracking Check will extend PVARP and limit tracking when programmed to On.
c
Check atrial sensing parameters after atrial sensing setup has completed.
RV parameters
Parameter Programmable values
RV Amplitude
0.13; 0.25; 0.38; 0.50; 0.63;
0.75; 0.88; 1.00; 1.13; 1.25;
1.38; 1.50
; 1.63; 1.75; 1.88;
2.00; 2.13; 2.25; 2.38; 2.50;
2.63; 2.75; 2.88; 3.00; 3.13;
3.25; 3.38; 3.50; 3.63; 3.75;
3.88; 4.00; 4.13; 4.25; 4.38;
4.50; 4.63; 4.75; 4.88; 5.00 V
RV Pulse Width 0.09; 0.15; 0.24
; 0.40; 1.00 ms
RV Sensitivity
0.45; 0.60; 0.90; 1.50; 2.00
;
2.80; 4.00; 5.60; 8.00; 11.30 mV
a,b
Acute Phase Remaining
Device Repositioned
(112 days) ; Off
RV Blanking
Blank Post VP 150; 160 … 240
; … 450 ms
Blank Post VS 120
; 130 … 350 ms
a
Carefully evaluate the possibility of increased susceptibility to EMI and
oversensing before changing the sensitivity threshold to its minimum (most
sensitive) setting. When susceptibility to interference is tested under the
conditions specified in ISO 14708-2 clause 27.4 and EN 45502-2-1 clause
27.5.1, the device may sense the interference if the sensitivity threshold
is programmed to the minimum value. The device complies with the
requirements of 14708-2 clause 27.4 and EN 45502-2-1 clause 27.5.1 when
the sensitivity threshold is programmed to 0.6 mV or higher.
b
Patients who require the lowest sensitivity threshold (0.45 mV) should be
under medical direction.
RV Capture Management
™
parameters
Parameter Programmable values
RV Capture Management Adaptive ; Monitor; Off
RV Amplitude Safety Margin 0.25; 0.50
… 1.50 V
Rate Response parameters
Parameter Programmable values
Rates
ADL Rate 60; 65 … 95
… 160 bpm
Upper Sensor Rate 80; 90 … 120
… 170 bpm
Rate Profile Optimization On ; Off
Adjust Rate Response
ADL Response 1; 2; 3
; 4; 5
Exertion Response 1; 2; 3
; 4; 5
Rate Response Additional Parameters
a
Activity Acceleration 15; 30 ; 60 s
Activity Deceleration Exercise
; 2.5; 5; 10 min
a
The following parameters and their programmed values are shown in the
Rate Response Additional Parameters window, but they must be adjusted in
the Tests - Exercise screen: Activity Vector, LR Setpoint, ADL Setpoint, UR
Setpoint. Tap Tests > Exercise to access these parameters.
MRI SureScan parameters
Parameter Programmable values
MRI SureScan On; Off
MRI Pacing Mode VOO; OVO
MRI Pacing Rate 60; 70; 75; 80; 90 … 120 bpm
Additional pacing features
Parameter Programmable values
Rate Hysteresis
a
Off ; 30; 40 … 80 bpm
a
The programmed value for Rate Hysteresis must be lower than the Lower
Rate value unless Rate Hysteresis is programmed to Off.
Data collection parameters
Data collection parameters
Parameter Programmable values
Device Date/Time
a
(enter current date and time)
Holter Telemetry Off
; 0.5; 1; 2; 4; 8; 16; 24; hr
a
The times and dates stored in episode records and other data are determined by the
Device Date/Time clock.
System test parameters
System test parameters
Parameter Selectable values
Pacing Threshold Test parameters
Threshold Test
Capture Management
a
Amplitude — Auto
Decrement
Decrement after 2; 3 … 15 pulses
Mode
b
(RV test) VVI; VOO
Lower Rate
30; 35 … 60; 70; 75; 80;
90 … 170 bpm
Amplitude
0.13; 0.25; 0.38; 0.50;
0.63 … 5.00 V
Pulse Width
0.09; 0.15; 0.24; 0.40;
1.00 ms
V. Pace Blanking 150; 160 … 450 ms
Sensing test parameters
Mode VVI; OVO
Lower Rate
30; 35 … 60; 70; 75; 80;
90 … 170 bpm
Exercise test parameters
Duration 5 min; 20 min
Activity Vector
c
Vector 1; Vector 2; Vector 3
LR Setpoint
c
0; 1; 2 … 40; 42 … 50
ADL Setpoint
c
5; 6 … 40; 42 … 80; 85 …100
UR Setpoint
c
15; 16 … 40; 42 … 80;
85 … 200
a
If the permanently programmed pacing mode is VOO, Capture Management is not
available for selection.
b
The selectable test values for this parameter depend on the permanently programmed
pacing mode.
c
These are the rate response additional parameters; however, they can only be
programmed from the Tests — Exercise screen. To see these parameters in the Rate
Response Additional Parameters window, tap Params > Rate Response… > Additional
Parameters….
Temporary test parameters
Temporary test parameters
Parameter Selectable values
Mode VVI; VOO; OVO
Lower Rate
30; 35; 40 … 60; 70; 75; 80;
90 … 170 bpm
Amplitude
0.13; 0.25; 0.38; 0.50;
0.63 … 5.00 V
Pulse Width
0.09; 0.15; 0.24; 0.40;
1.00 ms
Sensitivity
0.45; 0.60; 0.90; 1.50;
2.00; 2.80; 4.00; 5.60;
8.00; 11.30 mV
Nonprogrammable parameters
Nonprogrammable parameters
Parameter Selectable values
Pacing rate limit
(runaway pacing rate
protection)
195 bpm
Minimum input impedance 150 k Ω
Pacing output capacitance 2.2 μF
Manual atrial mechanical test parameters
Manual Atrial Mechanical test parameters
Parameter Selectable values
Temp. Mode VDD; VDI; ODO
Temp. Lower Rate
30; 35; 40 … 60; 70; 75; 80; 90
… 170 bpm
Temp. A Sensing Vector 1; 2; 3; 1+2; 1+3; 2+3; 1+2+3
Temp. A3 Threshold
1.0; 1.2; 1.4 … 4.0; 4.5; 5.0 …
10.0; Max m/s
2
Temp. A3 Window End 600; 625; 650 … 1,000 ms
Temp. A4 Threshold
0.7; 0.8; 0.9; 1.0; 1.2; 1.4 … 3.0;
3.5; 4.0 … 8.0 m/s
2
Brief Statement
MR Conditional dual chamber transcatheter pacing system with
SureScan
™
technology (VDD)
Indications
Micra
™
AV Model MC1AVR1 is indicated for use in patients who have
experienced one or more of the following conditions:
§ Paroxysmal or permanent high-grade AV block in the presence
of AF
§ Paroxysmal or permanent high-grade AV block in the absence of
AF, as an alternative to dual chamber pacing, when a dual-chamber
transvenous pacing system is considered dicult, high risk, or not
deemed necessary for eective therapy
§ Symptomatic bradycardia-tachycardia syndrome or sinus node
dysfunction (sinus bradycardia or sinus pauses), as an alternative to
atrial or dual chamber pacing, when a dual-chamber transvenous
pacing system is considered dicult, high risk, or not deemed
necessary for eective therapy
The device is also indicated for VDD pacing in patients with
adequate sinus rates who may benet from maintenance of
AV synchrony. The Micra AV device provides AV synchronous
ventricular pacing similar to a transvenous VDD system. The
implanted device depends on the appropriate sensing of atrial
mechanical signals to achieve AV synchrony. The level of AV
synchrony may vary in individual patients and may not be predictable
prior to implant.
Rate-responsive pacing is indicated to provide increased heart rate
appropriate to increasing levels of activity.
The device is designed to be used only in the right ventricle.
Contraindications
Micra AV Model MC1AVR1 is contraindicated for patients who have
the following types of medical devices implanted: an implanted
device that would interfere with the implant of the Micra device in
the judgment of the implanting physician, an implanted inferior vena
cava lter, a mechanical tricuspid valve, or an implanted cardiac
device providing active cardiac therapy that may interfere with the
sensing performance of the Micra device.
The device is contraindicated for patients who have the following
conditions: femoral venous anatomy unable to accommodate a
7.8 mm (23 French) introducer sheath or implant on the right side
of the heart (for example, due to obstructions or severe tortuosity),
morbid obesity that prevents the implanted device from obtaining
telemetry communication within ≤ 12.5 cm (4.9 in), or known
intolerance to the materials listed in the Instruction for Use, or to
heparin, or sensitivity to contrast media that cannot be adequately
premedicated, or if the steroid dose from this device cannot be
tolerated.
Warnings and Precautions
End of Service (EOS) — When the EOS condition is met, the clinician
has the option of permanently programming the device to O and
leaving it in the heart, or retrieving the device, provided the device
has not yet become encapsulated. Removal of the Micra device
after it has become encapsulated may be dicult because of the
development of brotic tissue. If removal of the device is required, it
is recommended that the removal be performed by a clinician who
has expertise in the removal of implanted leads.
MRI conditions for use — Before an MRI scan is performed on
a patient implanted with the Micra device, the cardiology and
radiology professionals involved in this procedure must understand
the requirements specic to their tasks as dened in the device
manuals.
Rate-responsive mode may not be appropriate for patients who
cannot tolerate pacing rates above the programmed Lower Rate.
The patient’s age and medical condition should be considered by
physicians and patients as they select the pacing system, mode of
operation, and implant technique best suited to the individual.
Precautions should be taken before administering anticoagulant
agents, antiplatelet agents, or contrast media in patients with
known hypersensitivity to these agents.
The use of deactivated Micra devices in situ and an active Micra
device, or an active transvenous pacemaker or debrillator, has
not been clinically tested to determine whether EMI or physical
interaction is clinically signicant. Bench testing supports that
implantation of an active Micra device, or an active transvenous
pacemaker or debrillator, next to an inactivated Micra device is
unlikely to cause EMI or physical interaction. Post-approval studies
are planned to characterize risks of co-implanted, deactivated Micra
devices. Currently recommended end of device life care for a Micra
device may include the addition of a replacement device with or
without explantation of the Micra device, which should be turned o.
Patient activities and environments which present mechanical
vibrations to the patient can interfere with the mechanical sensing
of atrial contractions. This can result in a loss of AV synchrony.
Potential Complications
Potential complications include, but are not limited to, toxic/
allergic reaction, oversensing, pacemaker syndrome, cardiac
arrest, necrosis, surgical complications such as cardiac perforation,
pericardial eusion, cardiac tamponade, device embolization,
hematoma, AV stula, vessel dissection, infection, cardiac
inammation, and thrombosis.
See the device manuals for detailed information regarding the implant
procedure, indications, contraindications, warnings, precautions, MRI
conditions for use, and potential complications/adverse events. For
further information, please call Medtronic at 1-800-328-2518 and/or
consult the Medtronic website at medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on
the order of a physician.
UC202003944 EN ©2020 Medtronic.
Minneapolis, MN. All Rights Reserved.
Printed in USA. 01/2020
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USA
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