D284TRK Maximo II CRT-D
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
D284TRK Maximo II CRT-D
Information

Device Survival Probability


MAXIMO_II_CRT_SURV
    1 yr 2 yr 3 yr 4 yr at 57 mo          
% Excluding Normal Battery Depletion 100.0 99.7 99.3 98.5 98.2          
% Including Normal Battery Depletion 99.9 98.5 93.0 77.8 49.9          
#   13451 10921 7404 3034 241          
  • 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 VVE-DDDR
Max. Delivered Energy 35 J
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Connector Style CRT-D Style
Serial Number Prefix PZP
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 Release2008-09-17
CE Approval Date2008-03-14
Registered USA Implants15121
Estimated Active USA Implants9608
Normal Battery Depletions1173
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution33973
Normal Battery Depletions1239
Information

Malfunctions (USA)

Therapy Function Not Compromised 123
Electrical Component 3
Possible Early Battery Depletion 120
Therapy Function Compromised 3
Electrical Component 3
Information

Malfunctions (WW)

Therapy Function Not Compromised 134
Electrical Component 3
Possible Early Battery Depletion 131
Therapy Function Compromised 4
Electrical Component 4
Information

Recommended Replacement (RRT)

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

Information

Charge Time


D264TRM_D284TRK_D384TRx_D394TRx_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050