D334VRG Protecta VR
Implantable Cardioverter Defibrillator (ICD)
D334VRG Protecta VR
Information

Device Survival Probability

D3xxVRx_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 78.0 mo      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 99.9 99.9 99.9      
% Including Normal Battery Depletion 99.9 99.9 99.8 99.6 99.3 99.0 97.8      
#   26703 25030 23514 21249 15531 4436 521      
  • 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 VVE-VVIR
Max. Delivered Energy 35 J
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Connector Style Cx Style
Serial Number Prefix PSX
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 Release2011-03-25
CE Approval Date
Registered USA Implants6483
Estimated Active USA Implants5051
Normal Battery Depletions18
US Market Release2011-03-25
CE Approval Date
Estimated WW Distribution6611
Normal Battery Depletions18
Information

Malfunctions (USA)

Therapy Function Not Compromised 4
Battery 1
Electrical Component 3
Therapy Function Compromised 2
Electrical Component 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 4
Battery 1
Electrical Component 3
Therapy Function Compromised 2
Electrical Component 2
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% VVI pacing at 60 min-1, 2.5 V 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

D334VRx_D364VRx_CHRG
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Data as of January 31, 2018

www.medtronic.com/productperformance 601051