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 99.7 99.7 99.6 99.6 99.6 99.6 99.6            
% Including Normal Battery Depletion 99.8 99.6 99.2 98.9 98.3 97.5 96.0 93.4 88.5 80.2 66.1 49.6 37.1 24.1 20.2            
#   41044 33916 28096 23363 19470 16196 13469 11204 9114 7024 4824 2759 1357 340 158            
  • 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 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 Implants51673
Estimated Active USA Implants4591
Normal Battery Depletions3002
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution126722
Normal Battery Depletions3499
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 198
Electrical Component 5
Electrical Interconnect 191
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 12, 2018

www.medtronic.com/productperformance 626050