KDR401 Kappa 400 DR
Implantable Pulse Generator (IPG)
KDR401 Kappa 400 DR
Information

Device Survival Probability

KDR401_KDR403_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 103.0 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 99.7 99.6 99.3 98.8 97.5 93.9 78.3 36.6 1.2  
#   40249 37429 34638 31846 28694 24785 18001 6422 551  
  • 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 IS-1 UNI/BI
Serial Number Prefix PER
Mass 34.0 g
Volume 13.9 cc
Waveform N/A
X-Ray ID PER
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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) 7.8 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 Implants39374
Estimated Active USA Implants1889
Normal Battery Depletions7229
US Market Release1998-01-30
CE Approval Date1996-11-12
Estimated WW Distribution52434
Normal Battery Depletions7350
Information

Malfunctions (USA)

Therapy Function Not Compromised 14
Electrical Component 10
Electrical Interconnect 1
Possible Early Battery Depletion 1
Other 2
Therapy Function Compromised 9
Electrical Component 6
Electrical Interconnect 3
Information

Malfunctions (WW)

Therapy Function Not Compromised 20
Electrical Component 14
Electrical Interconnect 3
Possible Early Battery Depletion 1
Other 2
Therapy Function Compromised 23
Electrical Component 11
Electrical Interconnect 11
Other 1
Information

Elective Replacement (ERI)

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

Data as of April 14, 2016

www.medtronic.com/productperformance 426050