SD203 Sigma 200 D
Implantable Pulse Generator (IPG)
SD203 Sigma 200 D
Information

Device Survival Probability


SDR203_SD203_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr at 152 mo                
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 99.9 99.9 99.8 99.6 99.5 99.5 99.5 99.4 99.4                
% Including Normal Battery Depletion 100.0 99.9 99.9 99.7 99.4 98.8 97.2 94.2 90.2 83.4 70.3 53.2 33.3                
#   14205 12741 11334 10152 9017 7980 6944 5960 4986 3750 2240 859 115                
  • 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 DDD
Max. Delivered Energy N/A
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Connector Style 3.2mm Long Pin
Serial Number Prefix PJD
Mass 27.2 g
Volume 12.8 cc
Waveform N/A
X-Ray ID PJD
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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 11.7
Nominal 3.5 V (A, RV) 7.5 9.6
High 5.0 V (A, RV) 5.5 7.8
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 %Hide this content

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

Distribution Data

US Market Release1999-08-31
CE Approval Date1998-12-17
Registered USA Implants225
Estimated Active USA Implants28
Normal Battery Depletions17
US Market Release1999-08-31
CE Approval Date1998-12-17
Estimated WW Distribution21488
Normal Battery Depletions227
Information

Malfunctions (USA)

Therapy Function Not Compromised 0
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 80
Electrical Component 2
Electrical Interconnect 78
Information

Elective Replacement (ERI)

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

Data as of January 31, 2014

www.medtronic.com/productperformance 301050