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 9 yr 10 yr 11 yr 12 yr at 155.0 mo                
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.7 99.7 99.6 99.4 99.4 99.4 99.4 99.4 99.4                
% Including Normal Battery Depletion 99.7 99.4 99.0 98.0 95.3 87.9 70.0 38.4 23.2 21.2 20.4 20.0 19.3                
#   44540 41185 38105 34983 31058 25091 16332 6719 3259 2658 2088 1503 193                
  • 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

Customer Communications For This Model

  • There are no communications 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 Implants49639
Estimated Active USA Implants5377
Normal Battery Depletions10323
US Market Release2008-09-15
CE Approval Date
Estimated WW Distribution50530
Normal Battery Depletions10331
Information

Malfunctions (USA)

Therapy Function Not Compromised 115
Battery 14
Electrical Component 38
Possible Early Battery Depletion 50
Software/Firmware 9
Other 4
Therapy Function Compromised 37
Battery 21
Electrical Component 13
Possible Early Battery Depletion 1
Software/Firmware 1
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 116
Battery 14
Electrical Component 39
Possible Early Battery Depletion 50
Software/Firmware 9
Other 4
Therapy Function Compromised 37
Battery 21
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 December 1, 2023

www.medtronic.com/productperformance 951051