7231Cx GEM III VR
Implantable Cardioverter Defibrillator (ICD)
7231Cx GEM III VR
Information

Device Survival Probability

7231_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
% Excluding Normal Battery Depletion 99.9 99.9 99.8 99.8 99.8 99.7 99.7 99.7 99.7 99.7
% Including Normal Battery Depletion 99.3 98.8 98.1 97.3 95.5 86.3 73.6 49.9 18.5 4.7
#   15740 14055 12441 10949 9552 7901 6156 3750 1114 103
  • 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 ICD
NBD Code VVE-VVIR
Max. Delivered Energy 30J
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Connector Style Cx Style
Serial Number Prefix PJL
Mass 77g
Volume 39cc
Waveform Biphasic
X-Ray ID PJL
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Cx Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.3 4.7 5.0 5.2
Quarterly 6.0 6.8 7.4 7.8
Semi-annual 6.6 7.5 8.5 8.9
Footnote

Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation. Hide this content

Information

EOL Indication

Battery voltage less than or equal to 2.40V. The minimum time between ERI and End of Life is three months, assuming 100% VVI pacing at 60 ppm, 3 V, 0.4 ms; 500 ohm pacing load; and six 30 J charges.

Information

Distribution Data

US Market Release2000-12-12
CE Approval Date2000-12-08
Registered USA Implants17494
Estimated Active USA Implants1474
Normal Battery Depletions3915
US Market Release2000-12-12
CE Approval Date2000-12-08
Estimated WW Distribution33331
Normal Battery Depletions4108
Information

Malfunctions (USA)

Therapy Function Not Compromised 26
Battery 1
Electrical Component 21
Possible Early Battery Depletion 4
Therapy Function Compromised 10
Battery 1
Electrical Component 8
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 70
Battery 1
Electrical Component 57
Electrical Interconnect 1
Possible Early Battery Depletion 7
Software/Firmware 1
Other 3
Therapy Function Compromised 19
Battery 2
Electrical Component 16
Electrical Interconnect 1
Information

Elective Replacement (ERI)

Battery voltage less than or equal to 2.55V.

Information

Charge Time

7231_CHRG
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Data as of February 9, 2015

www.medtronic.com/productperformance 351052