W1DR01 Azure XT DR
Implantable Pulse Generator (IPG)
W1DR01 Azure XT DR
Information

Device Survival Probability

AZURE_DR_SURV
Loading...










    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 76.0 mo      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0      
% Including Normal Battery Depletion 100.0 100.0 99.9 99.8 99.5 99.2 99.2      
#   546679 400761 275773 172250 82477 10614 151      
  • 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 IPG
NBD Code OAE-DDDR
Max. Delivered Energy N/A
More
Connector Style IS-1 UNI/BI
Serial Number Prefix RNB
Mass 22.5 g
Volume 12.75 cc
Waveform N/A
X-Ray ID RNA
Hide this content
IS-1 UNI/BI
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 10.3 12.3
Nominal 3.5 V (A, RV) 7.6 10.0
High 5.0 V (A, RV) 5.0 7.4
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 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 % Hide this content

Information

Distribution Data

US Market Release2017-08-16
CE Approval Date2017-03-02
Registered USA Implants679717
Estimated Active USA Implants611942
Normal Battery Depletions437
US Market Release2017-08-16
CE Approval Date2017-03-02
Estimated WW Distribution700067
Normal Battery Depletions437
Information

Malfunctions (USA)

Therapy Function Not Compromised 124
Battery 3
Electrical Component 76
Possible Early Battery Depletion 3
Software/Firmware 21
Other 21
Therapy Function Compromised 13
Battery 2
Electrical Component 11
Information

Malfunctions (WW)

Therapy Function Not Compromised 156
Battery 4
Electrical Component 89
Possible Early Battery Depletion 3
Software/Firmware 23
Other 37
Therapy Function Compromised 14
Battery 2
Electrical Component 12
Information

EOS Indication

From the point that the RRT is set, the pacemaker will operate for approximately six months for typical pacemaker configurations during the normal operating life.

Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.

Data as of April 30, 2024

www.medtronic.com/productperformance 1001052