D154VRC Entrust VR
Implantable Cardioverter Defibrillator (ICD)
D154VRC Entrust VR
Information

Device Survival Probability

D144VRC_D154VRC_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 11 yr at 134.0 mo                  
% Excluding Normal Battery Depletion 99.9 99.9 99.8 99.7 99.4 99.1 98.8 98.7 98.7 98.4 97.9 97.9                  
% Including Normal Battery Depletion 99.6 99.2 98.9 98.4 97.5 92.1 84.8 76.2 61.8 40.8 20.4 16.9                  
#   12683 11492 10275 9077 8014 7014 6012 5100 3864 2175 614 218                  
  • 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

Advisories For This Model

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type ICD
NBD Code VVE-VVIR
Max. Delivered Energy 35 J
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Connector Style Cx Style
Serial Number Prefix PNT
Mass 68g
Volume 35cc
Waveform Biphasic
X-Ray ID PNT
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Cx Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.8 5.0 5.2 5.3
Quarterly 7.5 8.3 8.8 9.0
Semi-annual 9.0 10.0 10.7 11.0
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

EOS Indication

EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% VVI pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and six full-energy charges. EOL may be indicated before the end of three months if the device exceeds these conditions.

Information

Distribution Data

US Market Release2005-06-30
CE Approval Date2005-02-04
Registered USA Implants14466
Estimated Active USA Implants2355
Normal Battery Depletions3142
US Market Release2005-06-30
CE Approval Date2005-02-04
Estimated WW Distribution23650
Normal Battery Depletions3445
Information

Malfunctions (USA)

Therapy Function Not Compromised 98
Battery 15
Electrical Component 47
Possible Early Battery Depletion 24
Other 12
Therapy Function Compromised 35
Battery 4
Electrical Component 27
Other 4
Information

Malfunctions (WW)

Therapy Function Not Compromised 139
Battery 16
Electrical Component 77
Electrical Interconnect 1
Possible Early Battery Depletion 30
Software/Firmware 1
Other 14
Therapy Function Compromised 45
Battery 6
Electrical Component 35
Other 4
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.61v.

Information

Charge Time

D144VRC_D154VRC_CHRG
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050