X3SR01 Astra S SR
Implantable Pulse Generator (IPG)
X3SR01 Astra S SR
Information

Device Survival Probability

ASTRA_SR_SURV
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    at 0.0 mo                  
  • 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-VVIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix RNK
Mass 22.5 g
Volume 12.25 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) 13.1 15.6
Nominal 3.5 V (A, RV) 11.2 13.7
High 5.0 V (A, RV) 8.2 11.0
Footnote

Longevity estimates based on the following device usage.   Pace/Sense Mode VVI ; 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; EGM Prestorage ON Time 1 month Hide this content

Information

Distribution Data

US Market Release
CE Approval Date2017-03-02
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2017-03-02
Estimated WW Distribution8
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOL Indicator

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

Elective Replacement (ERI)

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

Data as of October 29, 2020

www.medtronic.com/productperformance 776050