KSR701 Kappa 700 SR
Implantable Pulse Generator (IPG)
KSR701 Kappa 700 SR
Information

Device Survival Probability

KSR700_KSR701_KSR703_KSR706_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 130.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 99.9 99.9 99.8 99.8 99.8                    
% Including Normal Battery Depletion 99.6 99.3 98.6 97.2 94.6 89.9 78.6 54.8 28.1 17.1 13.8                    
#   48205 41530 35582 30380 25559 21008 15799 8834 2818 851 139                    
  • 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 SSIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PHT
Mass 21.5 g
Volume 9.7 cc
Waveform N/A
X-Ray ID PHT
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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) 7.4 7.9
Nominal 3.5 V (A, RV) 6.5 7.5
High 5.0 V (A, RV) 4.9 6.2
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppmHide 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 Release1999-01-29
CE Approval Date1998-03-20
Registered USA Implants48465
Estimated Active USA Implants4545
Normal Battery Depletions4940
US Market Release1999-01-29
CE Approval Date1998-03-20
Estimated WW Distribution90311
Normal Battery Depletions5554
Information

Malfunctions (USA)

Therapy Function Not Compromised 3
Electrical Component 1
Electrical Interconnect 1
Possible Early Battery Depletion 1
Therapy Function Compromised 19
Electrical Component 2
Electrical Interconnect 17
Information

Malfunctions (WW)

Therapy Function Not Compromised 17
Electrical Component 10
Electrical Interconnect 4
Possible Early Battery Depletion 2
Software/Firmware 1
Therapy Function Compromised 74
Electrical Component 4
Electrical Interconnect 70
Information

Elective Replacement (ERI)

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

Data as of August 3, 2014

www.medtronic.com/productperformance 326050