W3DR01 Azure S DR
Implantable Pulse Generator (IPG)
W3DR01 Azure S DR
Information

Device Survival Probability

AZURE_DR_SURV
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    1 yr 2 yr 3 yr 4 yr at 55.0 mo          
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0          
% Including Normal Battery Depletion 100.0 100.0 99.9 99.7 99.7          
#   330209 207070 109863 27303 273          
  • 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 OOE-DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix RNJ
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 Implants46388
Estimated Active USA Implants41368
Normal Battery Depletions17
US Market Release2017-08-16
CE Approval Date2017-03-02
Estimated WW Distribution141742
Normal Battery Depletions17
Information

Malfunctions (USA)

Therapy Function Not Compromised 6
Electrical Component 5
Software/Firmware 1
Therapy Function Compromised 1
Electrical Component 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 11
Battery 1
Electrical Component 6
Software/Firmware 2
Other 2
Therapy Function Compromised 2
Electrical Component 2
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 July 27, 2022

www.medtronic.com/productperformance 876050