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

Device Survival Probability


EMDR01_EMDR02_SURV
    1 yr 2 yr 3 yr 4 yr at 49 mo          
% Excluding Normal Battery Depletion 100.0 100.0 100.0 98.4 97.4          
% Including Normal Battery Depletion 100.0 100.0 100.0 96.8 94.9          
#   156 153 141 106 100          
  • 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.
Information

Product Characteristics

Generator Type IPG
NBD Code DDDRP
Max. Delivered Energy N/A
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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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IS-1 UNI/BI
Information

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

Information

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.

Information

Distribution Data

US Market Release
CE Approval Date2008-09-30
Registered USA Implants111
Estimated Active USA Implants72
Normal Battery Depletions
US Market Release
CE Approval Date2008-09-30
Estimated WW Distribution5147
Normal Battery Depletions1
Information

Malfunctions (USA)

Therapy Function Not Compromised 11
Battery 11
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 145
Battery 138
Electrical Component 4
Possible Early Battery Depletion 3
Therapy Function Compromised 3
Electrical Component 1
Possible Early Battery Depletion 2
Information

Recommended Replacement (RRT)

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

Data as of January 31, 2014

www.medtronic.com/productperformance 301050