SDR203 Sigma 200 DR
Implantable Pulse Generator (IPG)
SDR203 Sigma 200 DR
Information

Device Survival Probability

SDR203_SD203_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 at 152.0 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 DDDR
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 Implants15642
Estimated Active USA Implants2834
Normal Battery Depletions997
US Market Release1999-08-31
CE Approval Date1998-12-17
Estimated WW Distribution38934
Normal Battery Depletions1267
Information

Malfunctions (USA)

Therapy Function Not Compromised 10
Electrical Component 1
Electrical Interconnect 9
Therapy Function Compromised 26
Electrical Component 2
Electrical Interconnect 23
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 31
Electrical Component 5
Electrical Interconnect 21
Software/Firmware 3
Other 2
Therapy Function Compromised 95
Electrical Component 2
Electrical Interconnect 92
Other 1
Information

Elective Replacement (ERI)

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

Data as of January 31, 2014

www.medtronic.com/productperformance 301050