7278 Maximo DR
Implantable Cardioverter Defibrillator (ICD)
7278 Maximo DR
Information

Device Survival Probability

7278_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 100.0 mo  
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.8 99.8 99.7 99.7 99.7 99.7  
% Including Normal Battery Depletion 99.4 99.1 98.5 96.9 88.8 66.3 35.6 7.2 2.0  
#   33859 30305 27180 23928 19800 13111 5957 836 116  
  • 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 PRM
Mass 77g
Volume 39cc
Waveform Biphasic
X-Ray ID PRM
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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 Release2003-10-06
CE Approval Date2003-10-28
Registered USA Implants37665
Estimated Active USA Implants4438
Normal Battery Depletions10297
US Market Release2003-10-06
CE Approval Date2003-10-28
Estimated WW Distribution54895
Normal Battery Depletions10473
Information

Malfunctions (USA)

Therapy Function Not Compromised 62
Electrical Component 24
Possible Early Battery Depletion 34
Other 4
Therapy Function Compromised 10
Electrical Component 9
Possible Early Battery Depletion 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 98
Electrical Component 51
Possible Early Battery Depletion 40
Software/Firmware 2
Other 5
Therapy Function Compromised 16
Electrical Component 15
Possible Early Battery Depletion 1
Information

Elective Replacement (ERI)

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

Information

Charge Time

7278_CHRG
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050