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 at 64.0 mo        
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.9 99.9 99.9        
% Including Normal Battery Depletion 99.9 99.7 99.5 99.4 99.0 99.0        
#   12480 10479 7652 4141 819 100        
  • 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

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

Distribution Data

US Market Release2008-09-17
CE Approval Date2008-03-14
Registered USA Implants12898
Estimated Active USA Implants10655
Normal Battery Depletions34
US Market Release2008-09-17
CE Approval Date2008-03-14
Estimated WW Distribution39070
Normal Battery Depletions41
Information

Malfunctions (USA)

Therapy Function Not Compromised 8
Electrical Component 3
Possible Early Battery Depletion 3
Software/Firmware 2
Therapy Function Compromised 3
Electrical Component 2
Software/Firmware 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 20
Battery 1
Electrical Component 12
Possible Early Battery Depletion 4
Software/Firmware 3
Therapy Function Compromised 8
Electrical Component 6
Software/Firmware 2
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, 2014

www.medtronic.com/productperformance 301050