EN1SR01 Ensura SR MRI
Implantable Pulse Generator (IPG)
EN1SR01 Ensura SR MRI
Information

Device Survival Probability

A3SR01_ENSR01_SURV
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    1 yr 2 yr at 29.0 mo              
% Excluding Normal Battery Depletion 100.0 100.0 100.0              
% Including Normal Battery Depletion 100.0 100.0 100.0              
#   11457 2325 175              
  • 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

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type IPG
NBD Code VVIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PTZ
Mass 22 g
Volume 12.7 cc
Waveform N/A
X-Ray ID PVX
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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) 11.9 12.9
Nominal 3.5 V (A, RV) 10.0 11.6
High 5.0 V (A, RV) 7.8 9.83
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 ; Hide this content

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

Distribution Data

US Market Release
CE Approval Date2014-04-24
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2014-04-24
Estimated WW Distribution26358
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.83V on 3 consecutive daily automatic measurements.

Data as of July 31, 2017

www.medtronic.com/productperformance 501050