C5TR01 Viva CRT-P
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
C5TR01 Viva CRT-P
Information

Device Survival Probability

C5TR01_C6TR01_SURV
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    1 yr 2 yr at 34.0 mo              
% Excluding Normal Battery Depletion 100.0 100.0 100.0              
% Including Normal Battery Depletion 100.0 99.9 99.9              
#   5686 2066 136              
  • 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 CRT-Pacing
NBD Code OAE-DDDR
Max. Delivered Energy N/A
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Connector Style CRT-P Style
Serial Number Prefix PZZ
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

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 Release
CE Approval Date2014-04-04
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2014-04-04
Estimated WW Distribution8453
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Elective Replacement (ERI)

Battery voltage less than or equal to 2.77V on 3 consecutive daily automatic measurements.

Data as of July 31, 2017

www.medtronic.com/productperformance 501050