KSR401 Kappa 400 SR
Implantable Pulse Generator (IPG)
KSR401 Kappa 400 SR
Information

Device Survival Probability

KSR401_KSR403_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
% Including Normal Battery Depletion 99.9 99.6 99.4 98.8 98.3 96.5 90.1 66.0 29.3 12.3
#   13614 11961 10463 9177 7931 6710 5217 2656 574 121
  • 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 SSIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PEU
Mass 28.0 g
Volume 11.6 cc
Waveform N/A
X-Ray ID PEU
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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) 7.9 8.4
Nominal 3.5 V (A, RV) 6.9 7.7
High 5.0 V (A, RV) 5.8 7.0
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 ppm; 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 Release1998-02-18
CE Approval Date1996-11-12
Registered USA Implants11788
Estimated Active USA Implants928
Normal Battery Depletions1238
US Market Release1998-02-18
CE Approval Date1996-11-12
Estimated WW Distribution21171
Normal Battery Depletions1280
Information

Malfunctions (USA)

Therapy Function Not Compromised 4
Electrical Component 3
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 6
Electrical Component 4
Electrical Interconnect 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
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