SSR306 Sigma 300 SR
Implantable Pulse Generator (IPG)
SSR306 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 170.0 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 99.3 98.9 98.4 97.5 96.0 93.4 88.5 80.2 66.1 49.6 37.1 24.3 20.6            
#   41043 33917 28097 23364 19471 16198 13471 11207 9116 7028 4722 2573 1235 282 161            
  • 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 5/6mm UNI
Serial Number Prefix PJH
Mass 21.6 g
Volume 10.8 cc
Waveform N/A
X-Ray ID PJH
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5/6mm UNI
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 Release1999-09-07
CE Approval Date1998-12-17
Registered USA Implants2216
Estimated Active USA Implants156
Normal Battery Depletions160
US Market Release1999-09-07
CE Approval Date1998-12-17
Estimated WW Distribution6211
Normal Battery Depletions234
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 1
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 3
Electrical Component 1
Electrical Interconnect 1
Other 1
Therapy Function Compromised 6
Electrical Interconnect 6
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 January 31, 2018

www.medtronic.com/productperformance 601051