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 at 41.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0            
% Including Normal Battery Depletion 99.9 99.9 99.8 99.8            
#   15537 8560 2434 293            
  • 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

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 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

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 Release2011-03-22
CE Approval Date
Registered USA Implants14483
Estimated Active USA Implants13321
Normal Battery Depletions8
US Market Release2011-03-22
CE Approval Date
Estimated WW Distribution15297
Normal Battery Depletions8
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Recommended Replacement (RRT)

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

Data as of August 3, 2014

www.medtronic.com/productperformance 326050