KDR403 Kappa 400 DR
Implantable Pulse Generator (IPG)
KDR403 Kappa 400 DR
Information

Device Survival Probability


KDR401_KDR403_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 107 mo  
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 99.9 99.9 99.9 99.9 99.9  
% Including Normal Battery Depletion 99.9 99.8 99.7 99.4 98.8 97.0 88.0 58.6 7.3  
#   44246 41117 37950 34857 31529 27770 21360 9814 645  
  • 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 DDDR
Max. Delivered Energy N/A
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Connector Style 3.2mm Long Pin
Serial Number Prefix PET
Mass 34.0 g
Volume 13.9 cc
Waveform N/A
X-Ray ID PET
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3.2mm Long Pin
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 7.8 8.5
Nominal 3.5 V (A, RV) 6.4 7.5
High 5.0 V (A, RV) 5.1 6.5
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 %; Minute Ventilation ON 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 Release1998-01-30
CE Approval Date1996-11-12
Registered USA Implants7309
Estimated Active USA Implants924
Normal Battery Depletions1046
US Market Release1998-01-30
CE Approval Date1996-11-12
Estimated WW Distribution10443
Normal Battery Depletions1312
Information

Malfunctions (USA)

Therapy Function Not Compromised 2
Electrical Component 1
Possible Early Battery Depletion 1
Therapy Function Compromised 4
Electrical Component 1
Electrical Interconnect 3
Information

Malfunctions (WW)

Therapy Function Not Compromised 3
Electrical Component 2
Possible Early Battery Depletion 1
Therapy Function Compromised 9
Electrical Component 5
Electrical Interconnect 4
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