SS303 Sigma 300 S
Implantable Pulse Generator (IPG)
SS303 Sigma 300 S
Information

Device Survival Probability

SSR303_SSR306_SS303_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 14 yr at 171.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 99.9 99.8 99.7 99.6 99.6 99.5 99.5 99.5 99.5 99.5            
% Including Normal Battery Depletion 99.7 99.5 99.2 98.8 98.2 97.3 95.6 92.7 87.2 77.8 62.0 42.1 26.8 11.9 8.2            
#   40289 33069 27161 22372 18405 15052 12245 9929 7912 5975 3922 2035 944 257 125            
  • 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

Customer Communications For This Model

  • There are no communications 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

Distribution Data

US Market Release1999-09-15
CE Approval Date1998-12-17
Registered USA Implants248
Estimated Active USA Implants36
Normal Battery Depletions
US Market Release1999-09-15
CE Approval Date1998-12-17
Estimated WW Distribution46621
Normal Battery Depletions134
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 8
Electrical Component 2
Electrical Interconnect 5
Possible Early Battery Depletion 1
Therapy Function Compromised 24
Electrical Component 1
Electrical Interconnect 22
Possible Early Battery Depletion 1
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

Elective Replacement (ERI)

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

Data as of October 11, 2021

www.medtronic.com/productperformance 826050