D164AWG Virtuoso DR
Implantable Cardioverter Defibrillator (ICD)
Non-Advisory Population
D164AWG Virtuoso DR
Information

Device Survival Probability


D154AWG_D16AWG_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 80 mo      
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.4 97.2 97.0 97.0      
% Including Normal Battery Depletion 99.9 99.7 99.4 97.9 89.2 69.2 37.7      
#   67740 62405 57121 51427 36734 14492 1068      
  • 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.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type ICD
NBD Code DDE-DDDR
Max. Delivered Energy 35 J
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Connector Style DR Style
Serial Number Prefix PVV
Mass 68 g
Volume 37 cc
Waveform Biphasic
X-Ray ID PVR
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DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.1 4.5 4.8 5.0
Quarterly 6.3 7.3 8.3 8.8
Semi-annual 7.3 8.7 10.1 11.0
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

EOS Indication

EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms; 500 Ohm pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3 months if the device exceeds these conditions.

Information

Distribution Data

US Market Release
CE Approval Date2006-03-07
Registered USA Implants8
Estimated Active USA Implants7
Normal Battery Depletions
US Market Release
CE Approval Date2006-03-07
Estimated WW Distribution17476
Normal Battery Depletions139
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 297
Electrical Component 287
Possible Early Battery Depletion 9
Software/Firmware 1
Therapy Function Compromised 6
Electrical Component 6
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.62V on 3 consecutive daily automatic measurments.

Information

Charge Time


D154AWG_D164AWG_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050