KDR901 Kappa 900 DR
Implantable Pulse Generator (IPG)
KDR901 Kappa 900 DR
Information

Device Survival Probability

KD901_KD903_KD906_KDR901_KDR903_KDR906_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 122.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 99.9 99.9 99.9 99.9 99.9                    
% Including Normal Battery Depletion 99.7 99.6 99.3 98.7 97.6 95.3 86.2 60.1 27.5 6.0 1.9                    
#   108150 99181 90300 81810 73493 65140 53746 33317 12743 1536 469                    
  • 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
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Connector Style IS-1 UNI/BI
Serial Number Prefix PKM
Mass 27.1 g
Volume 12.1 cc
Waveform N/A
X-Ray ID PKM
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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) 7.7 8.6
Nominal 3.5 V (A, RV) 6.3 7.7
High 5.0 V (A, RV) 4.4 6.0
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 Release2002-01-09
CE Approval Date2001-09-28
Registered USA Implants120710
Estimated Active USA Implants9988
Normal Battery Depletions26909
US Market Release2002-01-09
CE Approval Date2001-09-28
Estimated WW Distribution182558
Normal Battery Depletions27058
Information

Malfunctions (USA)

Therapy Function Not Compromised 21
Electrical Component 16
Electrical Interconnect 4
Other 1
Therapy Function Compromised 50
Electrical Component 10
Electrical Interconnect 40
Information

Malfunctions (WW)

Therapy Function Not Compromised 32
Electrical Component 25
Electrical Interconnect 5
Other 2
Therapy Function Compromised 69
Electrical Component 17
Electrical Interconnect 52
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