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 at 23.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   64352 449                
  • 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 Implants19583
Estimated Active USA Implants19061
Normal Battery Depletions
US Market Release2017-08-16
CE Approval Date2017-03-02
Estimated WW Distribution38077
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
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 November 8, 2019

www.medtronic.com/productperformance 726050