DDBB1D4 Evera XT
Implantable Cardioverter Defibrillator (ICD)
DDBB1D4 Evera XT
Information

Device Survival Probability

EVERA_DR_SURV
Loading...










    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 101.0 mo  
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.8 99.8 99.7 99.7  
% Including Normal Battery Depletion 99.9 99.9 99.8 99.7 99.4 98.9 97.4 94.5 93.2  
#   193720 160725 125788 92962 63066 38346 19541 4538 216  
  • 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

Product Characteristics

Generator Type ICD
NBD Code DDE-DDDR
Max. Delivered Energy 36 J
More
Connector Style DF4 DR Style
Serial Number Prefix BWB
Mass 78 g
Volume 34 cc
Waveform Biphasic
X-Ray ID PXT
Hide this content
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 formation. Hide this content

Information

Distribution Data

US Market Release2013-04-03
CE Approval Date
Registered USA Implants59823
Estimated Active USA Implants36674
Normal Battery Depletions438
US Market Release2013-04-03
CE Approval Date
Estimated WW Distribution63474
Normal Battery Depletions438
Information

Malfunctions (USA)

Therapy Function Not Compromised 70
Battery 50
Electrical Component 14
Electrical Interconnect 2
Possible Early Battery Depletion 2
Other 2
Therapy Function Compromised 42
Battery 32
Electrical Component 10
Information

Malfunctions (WW)

Therapy Function Not Compromised 70
Battery 50
Electrical Component 14
Electrical Interconnect 2
Possible Early Battery Depletion 2
Other 2
Therapy Function Compromised 42
Battery 32
Electrical Component 10
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

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.73V on 3 consecutive daily automatic measurments.

Information

Charge Time

BLACKWELL_DR_CHRG
Loading...

Data as of December 16, 2021

www.medtronic.com/productperformance 851050