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

Device Survival Probability

AZURE_DR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 65.0 mo        
% Excluding Normal Battery Depletion 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 99.5        
#   428893 295376 183341 92198 16074 224        
  • 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
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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
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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 Implants556721
Estimated Active USA Implants502775
Normal Battery Depletions223
US Market Release2017-08-16
CE Approval Date2017-03-02
Estimated WW Distribution577340
Normal Battery Depletions223
Information

Malfunctions (USA)

Therapy Function Not Compromised 86
Battery 2
Electrical Component 45
Possible Early Battery Depletion 1
Software/Firmware 19
Other 19
Therapy Function Compromised 13
Battery 2
Electrical Component 11
Information

Malfunctions (WW)

Therapy Function Not Compromised 114
Battery 2
Electrical Component 55
Possible Early Battery Depletion 1
Software/Firmware 21
Other 35
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 May 10, 2023

www.medtronic.com/productperformance 926050