EMDR01 EnRhythm MRI
Implantable Pulse Generator (IPG)
EMDR01 EnRhythm MRI

Device Survival Probability


    1 yr 2 yr 3 yr 4 yr at 55.0 mo          
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.8          
% Including Normal Battery Depletion 100.0 99.9 99.9 99.8 99.3          
#   58082 53479 37479 12913 725          
  • 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.

Performance Notes For This Model

    • There are no performance notes for this model.

Product Characteristics

Generator Type IPG
Max. Delivered Energy N/A
Connector Style IS-1 UNI/BI
Serial Number Prefix PTA
Mass 21.5 g
Volume 12.7 cc
Waveform N/A
X-Ray ID PTA and MRI symbol
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Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 9.7 11.2
Nominal 3.5 V (A, RV) 7.3 9.4
High 5.0 V (A, RV) 4.9 7.1

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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 %Hide this content


EOS Indication

From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.


Distribution Data

US Market Release
CE Approval Date2008-09-30
Registered USA Implants111
Estimated Active USA Implants47
Normal Battery Depletions7
US Market Release
CE Approval Date2008-09-30
Estimated WW Distribution5202
Normal Battery Depletions11

Malfunctions (USA)

Therapy Function Not Compromised 19
Battery 19
Therapy Function Compromised 0

Malfunctions (WW)

Therapy Function Not Compromised 320
Battery 308
Electrical Component 5
Possible Early Battery Depletion 7
Therapy Function Compromised 3
Electrical Component 1
Possible Early Battery Depletion 2

Recommended Replacement (RRT)

Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).

Data as of November 2, 2015

www.medtronic.com/productperformance 376051