D284VRC Maximo II VR
Implantable Cardioverter Defibrillator (ICD)
D284VRC Maximo II VR
Information

Device Survival Probability

MAXIMO_II_VR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr at 164.0 mo              
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.9 99.9 99.8 99.7 99.7 99.6 99.6 99.6 99.6 99.6 99.6              
% Including Normal Battery Depletion 99.8 99.6 99.4 99.2 98.8 98.1 95.3 89.2 75.3 54.6 45.9 44.7 44.3 43.8              
#   10873 10125 9423 8722 8029 7335 6489 5254 3408 1828 1208 861 433 103              
  • 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

Customer Communications For This Model

  • There are no communications for this model.
Information

Product Characteristics

Generator Type ICD
NBD Code VVE-VVIR
Max. Delivered Energy 35 J
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Connector Style Cx Style
Serial Number Prefix PZN
Mass 68 g
Volume 37 cc
Waveform Biphasic
X-Ray ID PUG
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Cx Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.3 4.7 4.9 5.0
Quarterly 6.7 7.5 8.1 8.4
Semi-annual 7.8 8.9 9.8 10.3
Footnote

Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; 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 Implants12861
Estimated Active USA Implants2097
Normal Battery Depletions1612
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution52046
Normal Battery Depletions1658
Information

Malfunctions (USA)

Therapy Function Not Compromised 23
Battery 10
Electrical Component 6
Possible Early Battery Depletion 4
Software/Firmware 3
Therapy Function Compromised 9
Battery 6
Electrical Component 2
Software/Firmware 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 56
Battery 22
Electrical Component 26
Possible Early Battery Depletion 4
Software/Firmware 4
Therapy Function Compromised 22
Battery 14
Electrical Component 6
Software/Firmware 2
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% VVI pacing at 60 min-1, 2.5 V 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

D264VRM_D284VRC_D384VRx_D394VRx_CHRG
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Data as of December 1, 2023

www.medtronic.com/productperformance 951051