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

Device Survival Probability

SECURA_DR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 101.0 mo  
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.8 99.7 99.7 99.6 99.6  
% Including Normal Battery Depletion 99.6 99.4 99.1 98.2 95.4 88.3 72.0 41.4 21.3  
#   45387 42535 39942 37062 33183 26052 16120 3704 517  
  • 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

Distribution Data

US Market Release2008-09-15
CE Approval Date
Registered USA Implants49909
Estimated Active USA Implants15513
Normal Battery Depletions8053
US Market Release2008-09-15
CE Approval Date
Estimated WW Distribution50510
Normal Battery Depletions8054
Information

Malfunctions (USA)

Therapy Function Not Compromised 110
Battery 11
Electrical Component 36
Possible Early Battery Depletion 50
Software/Firmware 9
Other 4
Therapy Function Compromised 29
Battery 13
Electrical Component 13
Possible Early Battery Depletion 1
Software/Firmware 1
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 111
Battery 11
Electrical Component 37
Possible Early Battery Depletion 50
Software/Firmware 9
Other 4
Therapy Function Compromised 29
Battery 13
Electrical Component 13
Possible Early Battery Depletion 1
Software/Firmware 1
Other 1
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

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
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Data as of October 12, 2018

www.medtronic.com/productperformance 626050