D154ATG Entrust AT
Implantable Cardioverter Defibrillator (ICD)
D154ATG Entrust AT
Information

Device Survival Probability


D144DRG_D154ATG_D154DRG_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 89 mo    
% Excluding Normal Battery Depletion 100.0 99.9 99.8 99.7 99.4 99.4 99.4 99.4    
% Including Normal Battery Depletion 99.8 99.6 99.1 97.8 90.5 69.2 32.2 4.4    
#   26335 24105 21695 19181 15658 10024 3112 370    
  • 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 DDE-DDDR
Max. Delivered Energy 35 J
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Connector Style DR Style
Serial Number Prefix PNR
Mass 68g
Volume 35cc
Waveform Biphasic
X-Ray ID PNR
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DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.8 4.2 4.4 4.6
Quarterly 5.5 6.1 6.8 7.0
Semi-annual 6.1 7.0 7.9 8.3
Footnote

Longevity estimates based on the following device usage. Pacing Mode DDD; Atrial Lower Pacing Rate 60ppm; Ventricular Lower Pacing Rate 60ppm; Atrial Pulse Width 0.4ms; Ventricular Pulse Width 0.4ms; Atrial Pulse Amplitude 3V; Ventricular Pulse Amplitude 3V; Atrial Impedance 510ohms; Ventricle Impedance 510ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; Atrial Fib percentage of time 0%; 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% DDD 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 Implants28176
Estimated Active USA Implants5458
Normal Battery Depletions7036
US Market Release2005-06-30
CE Approval Date2005-02-04
Estimated WW Distribution37800
Normal Battery Depletions7608
Information

Malfunctions (USA)

Therapy Function Not Compromised 109
Electrical Component 29
Electrical Interconnect 1
Possible Early Battery Depletion 75
Software/Firmware 3
Other 1
Therapy Function Compromised 14
Electrical Component 14
Information

Malfunctions (WW)

Therapy Function Not Compromised 179
Electrical Component 77
Electrical Interconnect 3
Possible Early Battery Depletion 93
Software/Firmware 4
Other 2
Therapy Function Compromised 22
Battery 2
Electrical Component 20
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.61V.

Information

Charge Time


D144DRG_D154ATG_D154DRG_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050