W1TR03 Solara CRTP MRI
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
W1TR03 Solara CRTP MRI
Information

Device Survival Probability

W1TRXX_SURV
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    1 yr 2 yr at 27.0 mo              
% Excluding Normal Battery Depletion 100.0 100.0 100.0              
% Including Normal Battery Depletion 99.9 99.9 99.9              
#   2909 425 122              
  • 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

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 RNS
Mass 30 g
Volume 19.9 cc
Waveform N/A
X-Ray ID RNP
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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 10.9
Nominal 3.5 V (A, RV) 6.9 8.5
High 5.0 V (A, RV) 3.9 6.0
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 Release2017-05-06
CE Approval Date
Registered USA Implants1628
Estimated Active USA Implants1543
Normal Battery Depletions
US Market Release2017-05-06
CE Approval Date
Estimated WW Distribution2205
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOL Indicator

6 months after RRT

Information

Recommended Replacement (RRT)

180 days after 3 consecutive daily automatic measurements of battery voltage less than or equal to 2.63 V or immediately after 3 consecutive daily automatic measurements of less than or equal to 2.60 V, whichever comes first

Data as of November 8, 2019

www.medtronic.com/productperformance 726050