DVME3D4 Mirro
Implantable Cardioverter Defibrillator (ICD)
DVME3D4 Mirro
Information

Device Survival Probability

EVERA_VR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 130.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.8 99.7 99.6 99.5 99.4 99.3 99.3                    
% Including Normal Battery Depletion 100.0 99.9 99.7 99.6 99.4 99.1 98.9 98.7 98.3 97.8 96.1                    
#   52428 48822 45453 42319 39231 36059 33207 30001 19453 7802 218                    
  • 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 ICD
NBD Code VVE-VVIR
Max. Delivered Energy 36 J
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Serial Number Prefix CWR
Mass 77 g
Volume 33 cc
Waveform Biphasic
X-Ray ID PFZ
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Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.9 5.3 5.7 5.8
Quarterly 7.8 8.8 9.7 10.1
Semi-annual 8.5 9.7 10.7 11.3
Footnote

Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formationHide this content

Information

Distribution Data

US Market Release2018-03-01
CE Approval Date2017-11-10
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release2018-03-01
CE Approval Date2017-11-10
Estimated WW Distribution30451
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

EOS Indicator

From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Recommended Replacement (RRT)

Battery voltage less than 2.73V on 3 consecutive daily automatic measurements.

Information

Charge Time

BLACKWELL_VR_CHRG
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Data as of November 20, 2024

www.medtronic.com/productperformance 1026050