SVDD303 Sigma 300 VDD
Implantable Pulse Generator (IPG)
SVDD303 Sigma 300 VDD
Information

Device Survival Probability

SVDD303_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr                        
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 99.5 99.5                        
% Including Normal Battery Depletion 100.0 100.0 100.0 100.0 99.7 98.6 95.1 89.1 66.7                        
#   528 458 410 362 314 262 208 163 102                        
  • 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 VDD
Max. Delivered Energy N/A
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Connector Style 3.2mm Long Pin
Serial Number Prefix PJD
Mass 22.8 g
Volume 11.6 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) 8.9 9.7
Nominal 3.5 V (A, RV) 7.3 8.6
High 5.0 V (A, RV) 5.8 7.4
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Activity ONHide this content

Information

EOL Indication

3 months after ERI.

Information

Distribution Data

US Market Release1999-09-15
CE Approval Date1998-12-17
Registered USA Implants650
Estimated Active USA Implants44
Normal Battery Depletions81
US Market Release1999-09-15
CE Approval Date1998-12-17
Estimated WW Distribution21257
Normal Battery Depletions721
Information

Malfunctions (USA)

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

Malfunctions (WW)

Therapy Function Not Compromised 13
Electrical Component 1
Electrical Interconnect 11
Possible Early Battery Depletion 1
Therapy Function Compromised 94
Electrical Interconnect 94
Information

Elective Replacement (ERI)

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

Data as of August 3, 2016

www.medtronic.com/productperformance 451050