D164AWG Virtuoso DR
Implantable Cardioverter Defibrillator (ICD)
D164AWG Virtuoso DR
Information

Device Survival Probability

D154AWG_D16AWG_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 105.0 mo  
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.4 97.1 96.9 96.9 96.9 96.8  
% Including Normal Battery Depletion 99.6 99.3 98.9 97.4 89.1 69.8 43.5 23.6 8.3  
#   63436 58180 53019 48182 40953 29876 16947 5787 523  
  • 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 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 Implants10
Estimated Active USA Implants3
Normal Battery Depletions4
US Market Release
CE Approval Date2006-03-07
Estimated WW Distribution17389
Normal Battery Depletions366
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 347
Battery 1
Electrical Component 335
Possible Early Battery Depletion 10
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
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Data as of February 3, 2017

www.medtronic.com/productperformance 476050