D204TRM Consulta CRT-D
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
D204TRM Consulta CRT-D
Information

Device Survival Probability

CONSULTA_CRT_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 87.0 mo    
% Excluding Normal Battery Depletion 100.0 99.7 99.3 98.9 98.8 98.7 98.7 98.7    
% Including Normal Battery Depletion 99.5 98.1 92.6 79.8 56.1 26.8 15.7 13.3    
#   58003 52868 45930 35390 20225 6674 1509 287    
  • 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

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type CRT-Defib
NBD Code DDE-DDDR
Max. Delivered Energy 35 J
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Connector Style DF4 CRT-D Style
Serial Number Prefix PUC
Mass 73 g
Volume 40 cc
Waveform Biphasic
X-Ray ID PUG
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DF4 CRT-D Style
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Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.2 3.8 4.4 4.7
Quarterly 4.4 5.5 6.8 7.5
Semi-annual 4.8 6.2 7.9 9.0
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; Integrated bi-ventricular pacing RV+LV; Left Ventricle Impedance 510ohms; Left Ventricular Pulse Width 0.4ms; Left Ventricular Pulse Amplitude 3V; 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 Release2012-01-09
CE Approval Date
Registered USA Implants2099
Estimated Active USA Implants1017
Normal Battery Depletions442
US Market Release2012-01-09
CE Approval Date
Estimated WW Distribution2190
Normal Battery Depletions442
Information

Malfunctions (USA)

Therapy Function Not Compromised 3
Battery 1
Electrical Component 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 3
Battery 1
Electrical Component 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

EOS Indication

From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurments.

Information

Charge Time

D204TRM_D214TRM_D224TRK_D234TRK_CHRG
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Data as of January 31, 2018

www.medtronic.com/productperformance 601051