DVBC3D4 Evera S
Implantable Cardioverter Defibrillator (ICD)
DVBC3D4 Evera S
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
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.8 99.6 99.6 99.5 99.4 99.3
% Including Normal Battery Depletion 100.0 99.9 99.7 99.6 99.4 99.1 98.9 98.7 98.2 96.9
#   52410 48789 45352 42218 39145 35975 32330 21288 9285 256
  • 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 BWL
Mass 77 g
Volume 33 cc
Waveform Biphasic
X-Ray ID PXT
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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 formation. Hide this content

Information

Distribution Data

US Market Release2013-04-03
CE Approval Date2012-12-17
Registered USA Implants11103
Estimated Active USA Implants6988
Normal Battery Depletions24
US Market Release2013-04-03
CE Approval Date2012-12-17
Estimated WW Distribution33681
Normal Battery Depletions27
Information

Malfunctions (USA)

Therapy Function Not Compromised 12
Battery 9
Electrical Component 3
Therapy Function Compromised 7
Battery 5
Device-Related Current Pathway 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 33
Battery 25
Electrical Component 7
Electrical Interconnect 1
Therapy Function Compromised 18
Battery 13
Device-Related Current Pathway 3
Electrical Component 2
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 or equal to 2.73V on 3 consecutive daily automatic measurments.

Information

Charge Time

BLACKWELL_VR_CHRG
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Data as of December 1, 2023

www.medtronic.com/productperformance 951051