D224TRK Consulta CRT-D
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
D224TRK Consulta CRT-D
Information

Device Survival Probability


CONSULTA_CRT_SURV
    1 yr 2 yr 3 yr 4 yr at 57 mo          
% Excluding Normal Battery Depletion 100.0 99.7 99.3 98.6 98.5          
% Including Normal Battery Depletion 99.8 98.5 92.8 78.4 50.3          
#   59535 48909 33231 10902 488          
  • 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 CRT-D Style
Serial Number Prefix PUD
Mass 68 g
Volume 38 cc
Waveform Biphasic
X-Ray ID PUG
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CRT-D Style
Information

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

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

Distribution Data

US Market Release2008-09-15
CE Approval Date
Registered USA Implants65593
Estimated Active USA Implants43058
Normal Battery Depletions4326
US Market Release2008-09-15
CE Approval Date
Estimated WW Distribution66329
Normal Battery Depletions4327
Information

Malfunctions (USA)

Therapy Function Not Compromised 489
Electrical Component 25
Electrical Interconnect 1
Possible Early Battery Depletion 457
Software/Firmware 5
Other 1
Therapy Function Compromised 17
Electrical Component 17
Information

Malfunctions (WW)

Therapy Function Not Compromised 491
Electrical Component 27
Electrical Interconnect 1
Possible Early Battery Depletion 457
Software/Firmware 5
Other 1
Therapy Function Compromised 17
Electrical Component 17
Information

Recommended Replacement (RRT)

Battery voltage less than 2.63 V or Charge Time greater than 16 seconds.

Information

Charge Time


D204TRM_D214TRM_D224TRK_D234TRK_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050