D384VRG Cardia VR
Implantable Cardioverter Defibrillator (ICD)
D384VRG Cardia VR
Information

Device Survival Probability

D3xxVRx_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 145.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.9 99.8 99.8 99.7 99.7 99.7 99.7 99.7                
% Including Normal Battery Depletion 99.9 99.9 99.7 99.5 99.2 98.8 97.4 92.9 79.8 57.1 48.9 47.0 46.6                
#   25806 23987 22247 20577 19027 17454 15701 13107 8578 4306 2814 442 249                
  • 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 VVE-VVIR
Max. Delivered Energy 35 J
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Connector Style Cx Style
Serial Number Prefix PXK
Mass 68 g
Volume 37 cc
Waveform Biphasic
X-Ray ID PSI
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Cx Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.3 4.7 4.9 5.0
Quarterly 6.7 7.5 8.1 8.4
Semi-annual 7.8 8.9 9.8 10.3
Footnote

Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; 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 Release
CE Approval Date2011-01-12
Registered USA Implants1
Estimated Active USA Implants0
Normal Battery Depletions1
US Market Release
CE Approval Date2011-01-12
Estimated WW Distribution11568
Normal Battery Depletions1
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 7
Battery 5
Electrical Component 1
Other 1
Therapy Function Compromised 3
Battery 2
Electrical Component 1
Information

EOL Indicator

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

Recommended Replacement (RRT)

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

Information

Charge Time

D264VRM_D284VRC_D384VRx_D394VRx_CHRG
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Data as of November 20, 2024

www.medtronic.com/productperformance 1026050