DVBB1D1 Evera XT
Implantable Cardioverter Defibrillator (ICD)
DVBB1D1 Evera 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 9 yr 10 yr at 124.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.8 99.6 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 97.7 97.5                    
#   52431 48794 45402 42247 39173 36002 33070 26184 13541 3207 436                    
  • 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 Cx Style
Serial Number Prefix BWI
Mass 77 g
Volume 33 cc
Waveform Biphasic
X-Ray ID PXT
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Cx 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 Date
Registered USA Implants32235
Estimated Active USA Implants17878
Normal Battery Depletions78
US Market Release2013-04-03
CE Approval Date
Estimated WW Distribution36159
Normal Battery Depletions78
Information

Malfunctions (USA)

Therapy Function Not Compromised 51
Battery 44
Electrical Component 7
Therapy Function Compromised 21
Battery 16
Device-Related Current Pathway 2
Electrical Component 3
Information

Malfunctions (WW)

Therapy Function Not Compromised 51
Battery 44
Electrical Component 7
Therapy Function Compromised 21
Battery 16
Device-Related Current Pathway 2
Electrical Component 3
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 April 30, 2024

www.medtronic.com/productperformance 1001052