7288 Intrinsic
Implantable Cardioverter Defibrillator (ICD)
7288 Intrinsic
Information

Device Survival Probability

7288_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 87.0 mo    
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.8 99.7 99.7 99.7    
% Including Normal Battery Depletion 99.9 99.6 99.1 98.2 90.7 70.3 22.4 1.0    
#   28722 26379 23781 21023 17499 11642 2797 505    
  • 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-DDDR
Max. Delivered Energy 35J
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Connector Style DR Style
Serial Number Prefix PUB
Mass 76g
Volume 38cc
Waveform Biphasic
X-Ray ID PUB
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DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.7 4.1 4.3 4.5
Quarterly 5.3 6.1 6.8 7.1
Semi-annual 6.0 7.0 8.0 8.5
Footnote

Longevity estimates based on the following device usage. Pacing Mode DDD; Atrial Lower Pacing Rate 60ppm; Ventricular Lower Pacing Rate 60ppm; Atrial Pulse Width 0.4ms; Ventricular Pulse Width 0.4ms; Atrial Pulse Amplitude 3V; Ventricular Pulse Amplitude 3V; Atrial Impedance 510ohms; Ventricle Impedance 510ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Atrial Fib percentage of time 0%; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation. Hide this content

Information

EOL Indication

EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% VVI pacing at 60 ppm, 3 V, 0.4 ms; 500 Ohm pacing load; and six 30 J charges. EOL may be indicated before the end of three months if the device exceeds these conditions.

Information

Distribution Data

US Market Release2004-06-21
CE Approval Date2004-05-04
Registered USA Implants30665
Estimated Active USA Implants3227
Normal Battery Depletions9607
US Market Release2004-06-21
CE Approval Date2004-05-04
Estimated WW Distribution39375
Normal Battery Depletions9864
Information

Malfunctions (USA)

Therapy Function Not Compromised 64
Battery 2
Electrical Component 27
Possible Early Battery Depletion 33
Software/Firmware 1
Other 1
Therapy Function Compromised 7
Electrical Component 5
Other 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 82
Battery 2
Electrical Component 39
Possible Early Battery Depletion 37
Software/Firmware 2
Other 2
Therapy Function Compromised 9
Electrical Component 7
Other 2
Information

Elective Replacement (ERI)

Battery voltage less than or equal to 2.62v or charge time greater than 16 seconds.

Information

Charge Time

7288_CHRG
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050