DDMB1D4 Evera MRI XT
Implantable Cardioverter Defibrillator (ICD)
DDMB1D4 Evera MRI XT
Information

Device Survival Probability

EVERA_DR_SURV
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    1 yr 2 yr 3 yr at 44.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0            
% Including Normal Battery Depletion 100.0 99.9 99.8 99.8            
#   63542 35888 11840 175            
  • 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 36 J
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Connector Style DF4 DR Style
Serial Number Prefix PFZ
Mass 78 g
Volume 34 cc
Waveform Biphasic
X-Ray ID PFZ
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DF4 DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.1 4.6 5.1 5.4
Quarterly 5.9 7.0 8.3 9.0
Semi-annual 6.2 7.6 9.0 9.8
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 formationHide 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 Release2015-09-11
CE Approval Date
Registered USA Implants17740
Estimated Active USA Implants17344
Normal Battery Depletions2
US Market Release2015-09-11
CE Approval Date
Estimated WW Distribution20727
Normal Battery Depletions2
Information

Malfunctions (USA)

Therapy Function Not Compromised 4
Electrical Component 3
Electrical Interconnect 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 4
Electrical Component 3
Electrical Interconnect 1
Therapy Function Compromised 0
Information

Recommended Replacement (RRT)

Battery voltage less than 2.73V on 3 consecutive daily automatic measurements.

Information

Charge Time

BLACKWELL_DR_CHRG
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Data as of February 3, 2017

www.medtronic.com/productperformance 476050