E2DR06 EnPulse DR
Implantable Pulse Generator (IPG)
E2DR06 EnPulse DR
Information

Device Survival Probability

E2D01_E2D03_E2DR01_E2DR03_E2DR06_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr at 133.0 mo                  
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                  
% Including Normal Battery Depletion 99.5 99.4 99.2 98.7 97.8 96.1 90.0 70.1 38.4 13.7 3.7 3.0                  
#   87938 80802 73859 67310 60879 54639 46996 33354 15985 4717 681 396                  
  • 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

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Product Characteristics

Generator Type IPG
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style 5/6mm UNI
Serial Number Prefix PNH
Mass 28.5 g
Volume 14.2 cc
Waveform N/A
X-Ray ID PNH
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5/6mm UNI
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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 Release2004-02-20
CE Approval Date2003-09-08
Registered USA Implants1625
Estimated Active USA Implants163
Normal Battery Depletions320
US Market Release2004-02-20
CE Approval Date2003-09-08
Estimated WW Distribution2565
Normal Battery Depletions368
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Possible Early Battery Depletion 1
Therapy Function Compromised 1
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Possible Early Battery Depletion 1
Therapy Function Compromised 1
Electrical Interconnect 1
Information

Elective Replacement (ERI)

Telemetry indication. Rate and mode change to 65 ppm and VVI (V0O/65 with magnet).

Data as of July 31, 2017

www.medtronic.com/productperformance 501050