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 102.0 mo  
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.7 99.7 99.6 99.4 99.4  
% Including Normal Battery Depletion 99.7 99.5 99.2 98.4 95.6 87.6 72.4 48.8 32.2  
#   17584 16429 15445 14339 12587 9432 4983 1240 217  
  • 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

Distribution Data

US Market Release2008-09-17
CE Approval Date2008-03-14
Registered USA Implants20093
Estimated Active USA Implants7357
Normal Battery Depletions2677
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution46157
Normal Battery Depletions2703
Information

Malfunctions (USA)

Therapy Function Not Compromised 51
Battery 5
Electrical Component 14
Possible Early Battery Depletion 30
Other 2
Therapy Function Compromised 12
Battery 6
Electrical Component 5
Possible Early Battery Depletion 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 65
Battery 9
Electrical Component 20
Possible Early Battery Depletion 31
Software/Firmware 2
Other 3
Therapy Function Compromised 17
Battery 9
Electrical Component 7
Possible Early Battery Depletion 1
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

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 January 31, 2018

www.medtronic.com/productperformance 601051