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

Device Survival Probability

E1DR01_E1DR03_E1DR06_SURV
Loading...










    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 124.0 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                    
% Including Normal Battery Depletion 99.7 99.6 99.2 98.4 97.4 96.1 87.5 65.1 34.2 10.8 6.3                    
#   6213 5761 5313 4845 4415 3985 3316 2224 1025 251 120                    
  • 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
More
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
Hide this content
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 Implants6846
Estimated Active USA Implants739
Normal Battery Depletions1688
US Market Release2003-12-18
CE Approval Date
Estimated WW Distribution6930
Normal Battery Depletions1689
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 February 9, 2015

www.medtronic.com/productperformance 351052