D154AWG Virtuoso DR
Implantable Cardioverter Defibrillator (ICD)
D154AWG 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 at 89.0 mo    
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.4 97.2 97.1 97.0 97.0    
% Including Normal Battery Depletion 99.8 99.6 99.3 97.9 90.0 70.7 43.3 25.7    
#   67678 62378 57179 52045 42986 23836 4953 430    
  • 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 PUL
Mass 68g
Volume 37cc
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 bpm, 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 Release2006-05-12
CE Approval Date
Registered USA Implants72697
Estimated Active USA Implants29932
Normal Battery Depletions11190
US Market Release2006-05-12
CE Approval Date
Estimated WW Distribution73416
Normal Battery Depletions11197
Information

Malfunctions (USA)

Therapy Function Not Compromised 1415
Battery 4
Electrical Component 1270
Electrical Interconnect 2
Possible Early Battery Depletion 134
Software/Firmware 1
Other 4
Therapy Function Compromised 29
Electrical Component 26
Possible Early Battery Depletion 1
Other 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 1423
Battery 4
Electrical Component 1276
Electrical Interconnect 2
Possible Early Battery Depletion 134
Software/Firmware 2
Other 5
Therapy Function Compromised 29
Electrical Component 26
Possible Early Battery Depletion 1
Other 2
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.62v.

Information

Charge Time

D154AWG_D164AWG_CHRG
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050