C2TR01 Syncra CRT-P
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
C2TR01 Syncra 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 OOE-DDDR
Max. Delivered Energy N/A
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Connector Style CRT-P Style
Serial Number Prefix PZX
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 Date2010-05-11
Registered USA Implants10230
Estimated Active USA Implants5608
Normal Battery Depletions508
US Market Release2011-03-22
CE Approval Date2010-05-11
Estimated WW Distribution52715
Normal Battery Depletions514
Information

Malfunctions (USA)

Therapy Function Not Compromised 6
Possible Early Battery Depletion 5
Other 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 10
Electrical Component 2
Possible Early Battery Depletion 6
Software/Firmware 1
Other 1
Therapy Function Compromised 1
Other 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