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 at 107.0 mo  
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.9 99.9 99.9 99.8 99.8 99.7  
% Including Normal Battery Depletion 99.8 99.6 99.5 99.3 98.8 98.1 95.6 89.4 71.8  
#   11250 10547 9935 9238 8298 6959 4971 2298 148  
  • 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-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 Implants13037
Estimated Active USA Implants7413
Normal Battery Depletions453
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution50310
Normal Battery Depletions482
Information

Malfunctions (USA)

Therapy Function Not Compromised 17
Battery 5
Electrical Component 6
Possible Early Battery Depletion 3
Software/Firmware 3
Therapy Function Compromised 5
Battery 2
Electrical Component 2
Software/Firmware 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 46
Battery 14
Electrical Component 25
Possible Early Battery Depletion 3
Software/Firmware 4
Therapy Function Compromised 10
Battery 3
Electrical Component 5
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 January 31, 2018

www.medtronic.com/productperformance 601051