E2VDD01 EnPulse 2 VDD
Implantable Pulse Generator (IPG)
E2VDD01 EnPulse 2 VDD
Information

Device Survival Probability

E2VDD01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0    
% Including Normal Battery Depletion 100.0 100.0 100.0 99.6 98.5 90.6 66.9 54.8    
#   709 655 603 551 498 419 178 104    
  • 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 VDD
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PMV
Mass 23.6 g
Volume 11.1 cc
Waveform N/A
X-Ray ID PMV
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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) 6.1 6.5
Nominal 3.5 V (A, RV) 5.5 6.2
High 5.0 V (A, RV) 4.3 5.4
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 Date2003-09-08
Registered USA Implants556
Estimated Active USA Implants105
Normal Battery Depletions83
US Market Release2003-12-18
CE Approval Date2003-09-08
Estimated WW Distribution9461
Normal Battery Depletions221
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
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