E2DR01 EnPulse 2 DR
Implantable Pulse Generator (IPG)
E2DR01 EnPulse 2 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 at 114.0 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 99.8 99.7 99.5 99.1 98.3 96.8 91.3 73.8 43.5 15.8
#   94823 87640 80591 73942 67438 61244 54093 37924 9306 573
  • 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 PNB
Mass 27.1 g
Volume 12.2 cc
Waveform N/A
X-Ray ID PNB
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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 Release2004-02-20
CE Approval Date2003-09-08
Registered USA Implants97065
Estimated Active USA Implants27556
Normal Battery Depletions14617
US Market Release2004-02-20
CE Approval Date2003-09-08
Estimated WW Distribution141247
Normal Battery Depletions14749
Information

Malfunctions (USA)

Therapy Function Not Compromised 20
Electrical Component 18
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 5
Battery 1
Electrical Component 3
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 29
Electrical Component 24
Possible Early Battery Depletion 2
Other 3
Therapy Function Compromised 8
Battery 1
Electrical Component 6
Electrical Interconnect 1
Information

Elective Replacement (ERI)

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

Data as of August 3, 2014

www.medtronic.com/productperformance 326050