D204DRM Secura DR
Implantable Cardioverter Defibrillator (ICD)
D204DRM 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 at 93.0 mo    
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.8 99.7 99.7 99.6    
% Including Normal Battery Depletion 99.7 99.5 99.1 98.2 95.6 88.9 74.0 33.9    
#   45339 42488 39845 35870 30102 19610 5673 120    
  • 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 DF4 DR Style
Serial Number Prefix PUF
Mass 73 g
Volume 41 cc
Waveform Biphasic
X-Ray ID PUG
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DF4 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; 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 Release2012-01-09
CE Approval Date
Registered USA Implants1882
Estimated Active USA Implants1572
Normal Battery Depletions8
US Market Release2012-01-09
CE Approval Date
Estimated WW Distribution1972
Normal Battery Depletions8
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Other 1
Therapy Function Compromised 2
Electrical Component 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Other 1
Therapy Function Compromised 2
Electrical Component 2
Information

Recommended Replacement (RRT)

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

Information

Charge Time

D204DRM_D214DRM_D224DRG_D234DRG_CHRG
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Data as of February 3, 2017

www.medtronic.com/productperformance 476050