EN1DR01 Ensura MRI
Implantable Pulse Generator (IPG)
EN1DR01 Ensura MRI
Information

Device Survival Probability

A2DR01_A3DR01_A5DR01_EN1DR01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 64.0 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 99.9 99.7 99.0        
#   287456 194101 111968 44887 9071 969        
  • 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 OOE-DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PZW
Mass 22g
Volume 12.7cc
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) 8.9 10.2
Nominal 3.5 V (A, RV) 6.9 8.6
High 5.0 V (A, RV) 4.3 6.2
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 Release
CE Approval Date2010-06-23
Registered USA Implants13
Estimated Active USA Implants11
Normal Battery Depletions
US Market Release
CE Approval Date2010-06-23
Estimated WW Distribution218926
Normal Battery Depletions1
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 20
Electrical Component 17
Electrical Interconnect 1
Possible Early Battery Depletion 2
Therapy Function Compromised 4
Electrical Component 4
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 2.83V on 3 consecutive daily automatic measurments.

Data as of October 12, 2018

www.medtronic.com/productperformance 626050