C4TR01 Consulta CRT-P
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
C4TR01 Consulta CRT-P
Information

Device Survival Probability

C2TR01_C3TR01_C4TR01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 93.0 mo    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 99.9 99.9 99.9 99.9    
% Including Normal Battery Depletion 99.9 99.8 99.5 98.1 95.8 91.8 84.2 58.7    
#   26671 23951 21390 18233 14209 9522 3922 374    
  • 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 PVX
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) 8.7 10.7
Nominal 3.5 V (A, RV) 6.0 8.2
High 5.0 V (A, RV) 3.3 5.1
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 Release2011-03-22
CE Approval Date
Registered USA Implants23541
Estimated Active USA Implants14824
Normal Battery Depletions966
US Market Release2011-03-22
CE Approval Date
Estimated WW Distribution23817
Normal Battery Depletions966
Information

Malfunctions (USA)

Therapy Function Not Compromised 5
Possible Early Battery Depletion 5
Therapy Function Compromised 2
Electrical Component 1
Possible Early Battery Depletion 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 5
Possible Early Battery Depletion 5
Therapy Function Compromised 2
Electrical Component 1
Possible Early Battery Depletion 1
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 measurments.

Data as of October 29, 2020

www.medtronic.com/productperformance 776050