D264DRM Maximo II DR
Implantable Cardioverter Defibrillator (ICD)
D264DRM 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 DF4 DR Style
Serial Number Prefix PUJ
Mass 73 g
Volume 41 cc
Waveform Biphasic
X-Ray ID PUG
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DF4 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 Release2012-01-09
CE Approval Date2010-07-22
Registered USA Implants7
Estimated Active USA Implants4
Normal Battery Depletions
US Market Release2012-01-09
CE Approval Date2010-07-22
Estimated WW Distribution5991
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Electrical Component 2
Therapy Function Compromised 0
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