KVDD901 Kappa 900 VDD
Implantable Pulse Generator (IPG)
KVDD901 Kappa 900 VDD
Information

Device Survival Probability

KVDD901_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 86.0 mo    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 99.8 99.8 99.8    
% Including Normal Battery Depletion 100.0 100.0 100.0 99.7 98.8 89.2 41.4 31.4    
#   763 705 649 592 542 433 151 128    
  • 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

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 PLE
Mass 23.6 g
Volume 11.1 cc
Waveform N/A
X-Ray ID PLE
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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) 6.2 6.6
Nominal 3.5 V (A, RV) 5.6 6.3
High 5.0 V (A, RV) 4.4 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 Release2002-01-09
CE Approval Date2001-09-28
Registered USA Implants566
Estimated Active USA Implants56
Normal Battery Depletions81
US Market Release2002-01-09
CE Approval Date2001-09-28
Estimated WW Distribution16008
Normal Battery Depletions119
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Other 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 5
Electrical Component 2
Software/Firmware 2
Other 1
Therapy Function Compromised 2
Electrical Component 1
Electrical Interconnect 1
Information

Elective Replacement (ERI)

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

Data as of August 3, 2014

www.medtronic.com/productperformance 326050