D264VRM Maximo II VR
Implantable Cardioverter Defibrillator (ICD)
D264VRM 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 14 yr at 174.0 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 99.6            
% Including Normal Battery Depletion 99.8 99.6 99.4 99.2 98.8 98.1 95.3 89.3 75.3 54.6 46.2 45.1 44.6 44.3 44.3            
#   10870 10122 9420 8721 8028 7335 6491 5259 3411 1860 1345 1077 777 356 138            
  • 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 DF4 VR Style
Serial Number Prefix PUZ
Mass 73 g
Volume 38 cc
Waveform Biphasic
X-Ray ID PUG
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DF4 VR Style
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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 Release2012-05-02
CE Approval Date2010-12-17
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release2012-05-02
CE Approval Date2010-12-17
Estimated WW Distribution10038
Normal Battery Depletions1
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Battery 2
Therapy Function Compromised 1
Battery 1
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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 November 20, 2024

www.medtronic.com/productperformance 1026050