W1TR05 Serena CRTP MRI
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
W1TR05 Serena CRTP MRI
Information

Device Survival Probability

W1TRXX_SURV
Loading...










    1 yr at 14.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   359 145                
  • 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
More
Connector Style CRT-P Style
Serial Number Prefix RNW
Mass 30 g
Volume 20 cc
Waveform N/A
X-Ray ID RNP
Hide this content
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 Release
CE Approval Date2017-02-10
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2017-02-10
Estimated WW Distribution823
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOS Indication

6 months after RRT

Information

Recommended Replacement (RRT)

180 days after 3 consecutive daily automatic measurements of ≤ 2.63 V or immediately after 3 consecutive daily automatic measurements of ≤ 2.60 V, whichever comes first

Data as of October 12, 2018

www.medtronic.com/productperformance 626050