SSR303 Sigma 300 SR
Implantable Pulse Generator (IPG)
SSR303 Sigma 300 SR
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 SSIR
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 Release1999-08-30
CE Approval Date1998-12-17
Registered USA Implants51296
Estimated Active USA Implants1908
Normal Battery Depletions3070
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution127796
Normal Battery Depletions3590
Information

Malfunctions (USA)

Therapy Function Not Compromised 11
Electrical Interconnect 10
Other 1
Therapy Function Compromised 47
Electrical Component 3
Electrical Interconnect 44
Information

Malfunctions (WW)

Therapy Function Not Compromised 38
Electrical Component 5
Electrical Interconnect 30
Software/Firmware 1
Other 2
Therapy Function Compromised 203
Electrical Component 5
Electrical Interconnect 196
Software/Firmware 1
Other 1
Information

EOL Indication

3 months after ERI.

Information

Elective Replacement (ERI)

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

Data as of October 11, 2021

www.medtronic.com/productperformance 826050