SDR303 Sigma 300 DR
Implantable Pulse Generator (IPG)
SDR303 Sigma 300 DR
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 15 yr            
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.8 99.7 99.6 99.5 99.4 99.4 99.3 99.3 99.2 99.2            
% Including Normal Battery Depletion 99.7 99.6 99.4 99.1 98.7 97.9 96.8 94.1 89.7 82.3 71.2 55.5 40.3 28.4 16.3            
#   88290 78248 69204 60881 53408 46779 40580 35102 30216 25237 19468 12189 6387 2646 270            
  • 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/RO
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 Implants105517
Estimated Active USA Implants12462
Normal Battery Depletions10642
US Market Release1999-08-26
CE Approval Date1998-12-17
Estimated WW Distribution191026
Normal Battery Depletions11217
Information

Malfunctions (USA)

Therapy Function Not Compromised 60
Electrical Component 9
Electrical Interconnect 49
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 226
Electrical Component 7
Electrical Interconnect 218
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 129
Electrical Component 14
Electrical Interconnect 110
Possible Early Battery Depletion 1
Software/Firmware 1
Other 3
Therapy Function Compromised 449
Electrical Component 12
Electrical Interconnect 436
Other 1
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)

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

Data as of October 12, 2018

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