E1DR03 EnPulse DR
Implantable Pulse Generator (IPG)
E1DR03 EnPulse DR
Information

Device Survival Probability

E1DR01_E1DR03_E1DR06_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 117.0 mo                      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                      
% Including Normal Battery Depletion 99.6 99.5 99.0 98.1 97.1 95.7 86.4 62.2 28.4 5.1                      
#   6002 5549 5099 4634 4199 3758 3068 1975 772 133                      
  • 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 DDDR
Max. Delivered Energy N/A
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Connector Style 3.2mm Long Pin
Serial Number Prefix PRB
Mass 28.1
Volume 13.0
Waveform N/A
X-Ray ID PRB
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3.2mm Long Pin
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 7.5 8.5
Nominal 3.5 V (A, RV) 6.2 7.6
High 5.0 V (A, RV) 4.4 5.9
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

EOL Indication

3 months after ERI

Information

Distribution Data

US Market Release2003-12-18
CE Approval Date
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release2003-12-18
CE Approval Date
Estimated WW Distribution
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Elective Replacement (ERI)

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

Data as of July 31, 2017

www.medtronic.com/productperformance 501050