SS103 Sigma 100 S
Implantable Pulse Generator (IPG)
SS103 Sigma 100 S
Information

Device Survival Probability

SS103_SS106_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 104.0 mo                        
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                        
% Including Normal Battery Depletion 100.0 100.0 99.8 99.8 99.0 99.0 97.9 96.4 91.2                        
#   600 473 371 294 225 189 154 122 100                        
  • 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 Date1998-12-17
Registered USA Implants774
Estimated Active USA Implants68
Normal Battery Depletions34
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution91638
Normal Battery Depletions168
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 7
Electrical Component 1
Electrical Interconnect 6
Therapy Function Compromised 94
Electrical Component 4
Electrical Interconnect 88
Possible Early Battery Depletion 1
Other 1
Information

Elective Replacement (ERI)

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

Data as of July 31, 2017

www.medtronic.com/productperformance 501050