C154DWK Concerto CRT-D DR
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
Non-Advisory Population
C154DWK Concerto CRT-D DR
Information

Device Survival Probability


C154DWK_C164AWK_C174AWK_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr at 66 mo        
% Excluding Normal Battery Depletion 100.0 99.8 99.5 98.4 96.9 96.9        
% Including Normal Battery Depletion 99.8 98.3 93.4 79.1 44.1 11.1        
#   72840 64155 53986 39678 12806 1364        
  • 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 CRT-Defib
NBD Code DDE-DDDR
Max. Delivered Energy 35 J
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Connector Style CRT-D Style
Serial Number Prefix PVR
Mass 68 g
Volume 38 cc
Waveform Biphasic
X-Ray ID PVR
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CRT-D Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.8 4.3 4.8 5.0
Quarterly 5.5 6.8 8.0 8.8
Semi-annual 6.3 8.0 9.8 10.9
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; Intergrated bi-ventricular pacing RV+LV; Left Ventricle Impedance 510ohms; Left Ventricular Pulse Width 0.4ms; Left Ventricular Pulse Amplitude 3V; 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

From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Distribution Data

US Market Release2006-05-12
CE Approval Date
Registered USA Implants81298
Estimated Active USA Implants18503
Normal Battery Depletions19048
US Market Release2006-05-12
CE Approval Date
Estimated WW Distribution82826
Normal Battery Depletions19052
Information

Malfunctions (USA)

Therapy Function Not Compromised 1363
Electrical Component 707
Electrical Interconnect 2
Possible Early Battery Depletion 648
Software/Firmware 3
Other 3
Therapy Function Compromised 41
Electrical Component 39
Electrical Interconnect 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 1374
Electrical Component 716
Electrical Interconnect 3
Possible Early Battery Depletion 648
Software/Firmware 3
Other 4
Therapy Function Compromised 43
Electrical Component 41
Electrical Interconnect 2
Information

Recommended Replacement (RRT)

Battery voltage less than 2.62 V or Charge Time greater than 16 seconds.

Information

Charge Time


C154DWK_C164AWK_C174AWK_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050