D284DRG Maximo II DR
Implantable Cardioverter Defibrillator (ICD)
D284DRG Maximo II DR
Information

Device Survival Probability

MAXIMO_II_DR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 99.0 mo  
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.7 99.7 99.6 99.5 99.5  
% Including Normal Battery Depletion 99.8 99.5 99.2 98.4 95.6 87.6 72.5 47.2 37.0  
#   17578 16424 15440 14309 12256 8828 4183 688 198  
  • 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 ICD
NBD Code VVE-DDDR
Max. Delivered Energy 35 J
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Connector Style DR Style
Serial Number Prefix PZM
Mass 68 g
Volume 37 cc
Waveform Biphasic
X-Ray ID PUG
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DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.6 4.1 4.5 4.7
Quarterly 5.1 6.0 7.0 7.5
Semi-annual 5.7 7.0 8.3 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; 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

The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 Ω pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.

Information

Distribution Data

US Market Release2008-09-17
CE Approval Date2008-03-14
Registered USA Implants20088
Estimated Active USA Implants8185
Normal Battery Depletions2313
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution46149
Normal Battery Depletions2338
Information

Malfunctions (USA)

Therapy Function Not Compromised 46
Battery 1
Electrical Component 13
Possible Early Battery Depletion 30
Other 2
Therapy Function Compromised 10
Battery 4
Electrical Component 5
Possible Early Battery Depletion 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 60
Battery 5
Electrical Component 19
Possible Early Battery Depletion 31
Software/Firmware 2
Other 3
Therapy Function Compromised 14
Battery 6
Electrical Component 7
Possible Early Battery Depletion 1
Information

Recommended Replacement (RRT)

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

Information

Charge Time

D264DRG_D284DRG_D384DRx_D394DRx_CHRG
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050