DTBA1D4 Viva XT
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
DTBA1D4 Viva XT
Information

Device Survival Probability

BRAVA_VIVA_SURV
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    1 yr 2 yr 3 yr 4 yr at 57.0 mo          
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.9 99.9          
% Including Normal Battery Depletion 99.9 99.8 99.1 97.2 95.1          
#   85672 66175 42511 17587 904          
  • 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.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type CRT-Defib
NBD Code DDE-DDDR
Max. Delivered Energy 36 J
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Connector Style DF4 CRT-D Style
Serial Number Prefix BLE
Mass 80 g
Volume 35 cc
Waveform Biphasic
X-Ray ID PXT
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DF4 CRT-D Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.6 4.3 4.9 5.3
Quarterly 4.9 6.3 7.8 8.8
Semi-annual 5.2 6.6 8.5 9.6
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; Integrated bi-ventricular pacing RV+LV; Left Ventricle Impedance 510ohms; Left Ventricular Pulse Width 0.4ms; Left Ventricular Pulse Amplitude 3V; 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 Release2013-01-29
CE Approval Date
Registered USA Implants19126
Estimated Active USA Implants16787
Normal Battery Depletions136
US Market Release2013-01-29
CE Approval Date
Estimated WW Distribution20006
Normal Battery Depletions136
Information

Malfunctions (USA)

Therapy Function Not Compromised 13
Battery 2
Electrical Component 10
Possible Early Battery Depletion 1
Therapy Function Compromised 3
Battery 1
Electrical Component 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 13
Battery 2
Electrical Component 10
Possible Early Battery Depletion 1
Therapy Function Compromised 3
Battery 1
Electrical Component 2
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_CRT-D_CHRG
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Data as of January 31, 2018

www.medtronic.com/productperformance 601051