D153VRC Entrust VR
Implantable Cardioverter Defibrillator (ICD)
D153VRC Entrust VR
Information

Device Survival Probability

D153VRC_SURV
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    1 yr 2 yr 3 yr at 37.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0            
% Including Normal Battery Depletion 100.0 98.5 98.5 98.5            
#   141 119 102 100            
  • 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.

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 30 J
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Connector Style Cx Style
Serial Number Prefix PNT
Mass 63 g
Volume 32 cc
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 4.4 4.7 4.9 5.0
Quarterly 6.8 7.4 7.9 8.1
Semi-annual 7.9 8.7 9.5 9.8
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 Release2005-06-14
CE Approval Date
Registered USA Implants165
Estimated Active USA Implants10
Normal Battery Depletions28
US Market Release2005-06-14
CE Approval Date
Estimated WW Distribution176
Normal Battery Depletions28
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Electrical Component 2
Therapy Function Compromised 0
Information

EOL 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

Elective Replacement (ERI)

Battery voltage less than or equal to 2.61V on 3 consecutive daily automatic measurments.

Data as of October 12, 2018

www.medtronic.com/productperformance 626050