SD203 Sigma 200 D
Implantable Pulse Generator (IPG)
SD203 Sigma 200 D
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 13 yr 14 yr at 169.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 99.8 99.6 99.5 99.4 99.4 99.2 99.1 99.1 99.1            
% Including Normal Battery Depletion 99.6 99.4 99.3 99.0 98.5 97.5 95.4 91.9 86.6 77.9 64.4 47.0 29.7 15.6 13.9            
#   12993 11522 10113 8933 7800 6766 5735 4822 4011 3179 2271 1296 593 135 105            
  • 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 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 Implants226
Estimated Active USA Implants16
Normal Battery Depletions19
US Market Release1999-08-31
CE Approval Date1998-12-17
Estimated WW Distribution21850
Normal Battery Depletions300
Information

Malfunctions (USA)

Therapy Function Not Compromised 0
Therapy Function Compromised 1
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 6
Electrical Component 1
Electrical Interconnect 5
Therapy Function Compromised 88
Electrical Component 2
Electrical Interconnect 86
Information

Elective Replacement (ERI)

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

Data as of July 31, 2017

www.medtronic.com/productperformance 501050