D224DRG Secura DR
Implantable Cardioverter Defibrillator (ICD)
D224DRG Secura DR
Information

Device Survival Probability


SECURA_DR_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr at 64 mo        
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.6 99.6        
% Including Normal Battery Depletion 99.8 99.6 99.3 98.4 95.5 95.4        
#   47092 40630 30449 13889 2275 106        
  • 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 PUG
Mass 68g
Volume 37cc
Waveform Biphasic
X-Ray ID PUG
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DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.6 4.1 4.5 4.7
Quarterly 5.1 6.0 7.0 7.5
Semi-annual 5.7 7.0 8.3 9.0
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; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation. Hide this content

Information

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% DDD pacing at 60 min-1, 2.5 V atrial and 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

Distribution Data

US Market Release2008-09-15
CE Approval Date
Registered USA Implants49693
Estimated Active USA Implants40160
Normal Battery Depletions338
US Market Release2008-09-15
CE Approval Date
Estimated WW Distribution50385
Normal Battery Depletions339
Information

Malfunctions (USA)

Therapy Function Not Compromised 63
Electrical Component 16
Possible Early Battery Depletion 37
Software/Firmware 9
Other 1
Therapy Function Compromised 12
Electrical Component 10
Possible Early Battery Depletion 1
Software/Firmware 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 64
Electrical Component 17
Possible Early Battery Depletion 37
Software/Firmware 9
Other 1
Therapy Function Compromised 12
Electrical Component 10
Possible Early Battery Depletion 1
Software/Firmware 1
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.

Information

Charge Time


D204DRM_D214DRM_D224DRG_D234DRG_CHRG

Data as of January 31, 2014

www.medtronic.com/productperformance 301050