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 at 106.0 mo  
% Excluding Normal Battery Depletion 100.0 99.9 99.8 99.7 99.5 99.2 98.9 98.9 98.9  
% Including Normal Battery Depletion 99.8 99.5 99.2 98.7 97.8 92.8 86.1 78.8 70.9  
#   13630 12409 11155 9923 8835 7800 6136 3357 117  
  • 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 Implants14468
Estimated Active USA Implants6201
Normal Battery Depletions1095
US Market Release2005-06-30
CE Approval Date2005-02-04
Estimated WW Distribution23681
Normal Battery Depletions1294
Information

Malfunctions (USA)

Therapy Function Not Compromised 85
Battery 7
Electrical Component 44
Possible Early Battery Depletion 24
Other 10
Therapy Function Compromised 19
Electrical Component 18
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 128
Battery 9
Electrical Component 75
Electrical Interconnect 1
Possible Early Battery Depletion 30
Software/Firmware 1
Other 12
Therapy Function Compromised 28
Battery 1
Electrical Component 26
Other 1
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 August 3, 2014

www.medtronic.com/productperformance 326050