SS203 Sigma 200 S
Implantable Pulse Generator (IPG)
SS203 Sigma 200 S
Information

Device Survival Probability

SSR203_SS203_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 11 yr 12 yr 13 yr at 159.0 mo              
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 99.9 99.8 99.8 99.7 99.6 99.6 99.6 99.6 99.6 99.6              
% Including Normal Battery Depletion 99.6 99.4 99.1 98.8 98.1 96.9 95.1 91.9 85.3 74.7 55.6 36.9 23.4 19.2              
#   9080 7460 6152 5106 4214 3485 2816 2324 1817 1337 826 406 175 114              
  • 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 SSI
Max. Delivered Energy N/A
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Connector Style 3.2mm Long Pin
Serial Number Prefix PJG
Mass 21.5 g
Volume 10.5 cc
Waveform N/A
X-Ray ID PJG
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3.2mm Long Pin
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 10.1 11.1
Nominal 3.5 V (A, RV) 8.2 9.8
High 5.0 V (A, RV) 6.4 8.4
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 Release1999-08-30
CE Approval Date
Registered USA Implants5
Estimated Active USA Implants0
Normal Battery Depletions1
US Market Release1999-08-30
CE Approval Date
Estimated WW Distribution20226
Normal Battery Depletions577
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 4
Electrical Component 3
Electrical Interconnect 1
Therapy Function Compromised 33
Electrical Component 1
Electrical Interconnect 32
Information

Elective Replacement (ERI)

Replacement message on programmer. Nonmagnet mode VVI 65 ppm Magnet mode VOO 65 ppm

Data as of July 31, 2017

www.medtronic.com/productperformance 501050