SD303 Sigma 300 D
Implantable Pulse Generator (IPG)
SD303 Sigma 300 D
Information

Device Survival Probability

SDR303_SDR306_SD303_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 174.0 mo            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.8 99.7 99.6 99.5 99.4 99.3 99.2 99.2 99.1 99.1            
% Including Normal Battery Depletion 99.6 99.5 99.2 98.9 98.5 97.7 96.5 93.6 88.8 80.7 67.9 49.4 29.9 12.5 1.9            
#   86584 76437 67287 58915 51346 44592 38188 32406 27139 21706 16091 9293 4044 1121 108            
  • 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

Customer Communications For This Model

  • There are no communications 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

Distribution Data

US Market Release1999-08-26
CE Approval Date1998-12-17
Registered USA Implants123
Estimated Active USA Implants17
Normal Battery Depletions8
US Market Release1999-08-26
CE Approval Date1998-12-17
Estimated WW Distribution44951
Normal Battery Depletions150
Information

Malfunctions (USA)

Therapy Function Not Compromised 0
Therapy Function Compromised 2
Electrical Interconnect 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 38
Electrical Component 5
Electrical Interconnect 30
Other 3
Therapy Function Compromised 134
Electrical Component 1
Electrical Interconnect 131
Other 2
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

Elective Replacement (ERI)

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

Data as of October 11, 2021

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