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 at 167.0 mo              
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 99.9 99.8 99.7 99.7 99.6 99.6 99.6 99.6 99.6              
% Including Normal Battery Depletion 99.7 99.6 99.3 98.9 98.4 97.6 96.1 93.4 88.7 80.5 66.8 50.6 39.0 26.2              
#   39671 33124 27606 22996 19192 15999 13338 11083 8741 6276 3997 2096 871 143              
  • 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.

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 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

3 months after ERI.

Information

Distribution Data

US Market Release1999-08-30
CE Approval Date1998-12-17
Registered USA Implants51689
Estimated Active USA Implants5541
Normal Battery Depletions2441
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution126724
Normal Battery Depletions2913
Information

Malfunctions (USA)

Therapy Function Not Compromised 11
Electrical Interconnect 9
Other 2
Therapy Function Compromised 46
Electrical Component 3
Electrical Interconnect 43
Information

Malfunctions (WW)

Therapy Function Not Compromised 38
Electrical Component 5
Electrical Interconnect 29
Software/Firmware 1
Other 3
Therapy Function Compromised 197
Electrical Component 5
Electrical Interconnect 190
Software/Firmware 1
Other 1
Information

Elective Replacement (ERI)

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

Data as of April 14, 2016

www.medtronic.com/productperformance 426050