D153ATG Entrust AT
Implantable Cardioverter Defibrillator (ICD)
D153ATG Entrust AT
Information

Device Survival Probability

D153ATG_D153DRG_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 65.0 mo        
% Excluding Normal Battery Depletion 99.8 99.8 99.2 98.3 97.6 97.6        
% Including Normal Battery Depletion 98.7 98.7 97.5 91.6 67.1 42.9        
#   410 376 339 278 194 107        
  • 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 DDE-DDDR
Max. Delivered Energy 30J
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Connector Style DR Style
Serial Number Prefix PNR
Mass 63g
Volume 33cc
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 3.5 3.8 4.1 4.2
Quarterly 4.8 5.4 6.0 6.3
Semi-annual 5.3 6.1 6.9 7.2
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

Distribution Data

US Market Release2005-06-30
CE Approval Date
Registered USA Implants459
Estimated Active USA Implants13
Normal Battery Depletions179
US Market Release2005-06-30
CE Approval Date
Estimated WW Distribution598
Normal Battery Depletions184
Information

Malfunctions (USA)

Therapy Function Not Compromised 7
Possible Early Battery Depletion 7
Therapy Function Compromised 1
Electrical Component 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 8
Electrical Component 1
Possible Early Battery Depletion 7
Therapy Function Compromised 1
Electrical Component 1
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 bpm, 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

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.61v.

Data as of April 11, 2019

www.medtronic.com/productperformance 651050