E2SR01 EnPulse 2 SR
Implantable Pulse Generator (IPG)
E2SR01 EnPulse 2 SR
Information

Device Survival Probability

E2SR01_E2SR03_E2SR06_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 102.0 mo  
% Excluding Normal Battery Depletion 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 99.3 98.6 97.1 93.9 84.0 57.7 14.4  
#   22615 19631 17131 14982 12829 10942 8435 2388 117  
  • 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 SSIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PMW
Mass 21.5 g
Volume 9.7 cc
Waveform N/A
X-Ray ID PMW
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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) 7.2 7.7
Nominal 3.5 V (A, RV) 6.3 7.3
High 5.0 V (A, RV) 4.8 6.1
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppmHide 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 Date2003-09-08
Registered USA Implants22530
Estimated Active USA Implants4818
Normal Battery Depletions1940
US Market Release2003-12-18
CE Approval Date2003-09-08
Estimated WW Distribution45329
Normal Battery Depletions2093
Information

Malfunctions (USA)

Therapy Function Not Compromised 3
Electrical Component 2
Possible Early Battery Depletion 1
Therapy Function Compromised 1
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 6
Electrical Component 5
Possible Early Battery Depletion 1
Therapy Function Compromised 3
Electrical Component 2
Other 1
Information

Elective Replacement (ERI)

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

Data as of January 31, 2014

www.medtronic.com/productperformance 301050