D334DRG Protecta DR
Implantable Cardioverter Defibrillator (ICD)
D334DRG Protecta DR
Information

Device Survival Probability

D3xxDRx_SURV
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    1 yr 2 yr at 34.0 mo              
% Excluding Normal Battery Depletion 100.0 99.9 99.9              
% Including Normal Battery Depletion 99.9 99.7 99.7              
#   41967 13808 267              
  • 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 PSP
Mass 68 g
Volume 37 cc
Waveform Biphasic
X-Ray ID PSI
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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; 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

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

Distribution Data

US Market Release2011-03-25
CE Approval Date
Registered USA Implants9693
Estimated Active USA Implants9076
Normal Battery Depletions10
US Market Release2011-03-25
CE Approval Date
Estimated WW Distribution9961
Normal Battery Depletions10
Information

Malfunctions (USA)

Therapy Function Not Compromised 6
Electrical Component 5
Possible Early Battery Depletion 1
Therapy Function Compromised 2
Electrical Component 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 6
Electrical Component 5
Possible Early Battery Depletion 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 measurements.

Information

Charge Time

D334DRx_D364DRx_CHRG
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050