E1DR01 EnPulse DR
Implantable Pulse Generator (IPG)
E1DR01 EnPulse DR
Information

Device Survival Probability


E1DR01_E1DR03_E1DR06_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 109 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 100.0 99.9 99.6 98.7 97.8 96.3 86.5 59.4 13.2 4.7
#   6223 5773 5325 4848 4406 3950 3175 1798 258 149
  • 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

Information

Product Characteristics

Generator Type IPG
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PRA
Mass 27.1 g
Volume 12.1 cc
Waveform N/A
X-Ray ID PRA
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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) 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

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 Release2003-12-18
CE Approval Date
Registered USA Implants6842
Estimated Active USA Implants955
Normal Battery Depletions1495
US Market Release2003-12-18
CE Approval Date
Estimated WW Distribution6930
Normal Battery Depletions1496
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Elective Replacement (ERI)

Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).

Data as of January 31, 2014

www.medtronic.com/productperformance 301050