C6TR01 Viva CRT-P
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
C6TR01 Viva CRT-P
Information

Device Survival Probability

C5TR01_C6TR01_SURV
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    1 yr 2 yr 3 yr 4 yr at 55.0 mo          
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0          
% Including Normal Battery Depletion 99.9 99.7 99.5 98.2 96.0          
#   7659 6876 5404 2144 217          
  • 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

Customer Communications For This Model

  • There are no communications for this model.
Information

Product Characteristics

Generator Type CRT-Pacing
NBD Code OAE-DDDR
Max. Delivered Energy N/A
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Connector Style CRT-P Style
Serial Number Prefix PVZ
Mass 26 g
Volume 15 cc
Waveform N/A
X-Ray ID PVX
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CRT-P Style
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 8.5 10.4
Nominal 3.5 V (A, RV) 5.8 8.0
High 5.0 V (A, RV) 3.2 5.0
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Left Ventricle Pulse Width 0.4 ms; Left Ventricle Pulse Amplitude same as A, RV; Left Ventricle Percent Paced 100 %; Left Ventricle Lead Impedance same as A, RV; EGM Prestorage ON ; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %Hide this content

Information

Distribution Data

US Market Release2014-07-09
CE Approval Date
Registered USA Implants9298
Estimated Active USA Implants7889
Normal Battery Depletions57
US Market Release2014-07-09
CE Approval Date
Estimated WW Distribution9706
Normal Battery Depletions57
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
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 2.77V on 3 consecutive daily automatic measurements.

Data as of April 10, 2020

www.medtronic.com/productperformance 751050