DVMB1D4 Evera MRI XT
Implantable Cardioverter Defibrillator (ICD)
DVMB1D4 Evera MRI XT
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 at 97.0 mo  
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.9 99.8 99.7 99.6 99.5 99.5  
% Including Normal Battery Depletion 100.0 99.9 99.7 99.6 99.4 99.2 98.9 98.6 98.6  
#   53603 49776 46209 42750 37533 23899 10520 786 241  
  • 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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Connector Style DF4 VR Style
Serial Number Prefix PKZ
Mass 77 g
Volume 33 cc
Waveform Biphasic
X-Ray ID PFZ
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DF4 VR Style
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 Release2015-09-11
CE Approval Date
Registered USA Implants21209
Estimated Active USA Implants15431
Normal Battery Depletions14
US Market Release2015-09-11
CE Approval Date
Estimated WW Distribution24088
Normal Battery Depletions14
Information

Malfunctions (USA)

Therapy Function Not Compromised 19
Battery 10
Electrical Component 6
Other 3
Therapy Function Compromised 20
Battery 20
Information

Malfunctions (WW)

Therapy Function Not Compromised 19
Battery 10
Electrical Component 6
Other 3
Therapy Function Compromised 20
Battery 20
Information

EOS Indication

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 measurments.

Information

Charge Time

BLACKWELL_VR_CHRG
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Data as of October 11, 2021

www.medtronic.com/productperformance 826050