7304 InSync Maximo
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
7304 InSync Maximo
Information

Device Survival Probability

7304_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 62.0 mo        
% Excluding Normal Battery Depletion 100.0 99.9 99.6 99.2 99.1 99.1        
% Including Normal Battery Depletion 99.7 98.1 92.3 74.3 20.8 6.1        
#   16895 14749 11875 7602 1255 428        
  • 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 CRT-Defib
NBD Code VVE-DDDR
Max. Delivered Energy 35 J
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Connector Style CRT-D Style
Serial Number Prefix PRL
Mass 78 g
Volume 40 cc
Waveform Biphasic
X-Ray ID PRL
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CRT-D Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.3 3.8 4.1 4.3
Quarterly 4.5 5.3 6.2 6.6
Semi-annual 5.0 6.0 7.1 7.7
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; Intergrated bi-ventricular pacing RV+LV; Left Ventricle Impedance 510ohms; Left Ventricular Pulse Width 0.4ms; Left Ventricular Pulse Amplitude 3V; Optivol ON; 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

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

Distribution Data

US Market Release2005-04-08
CE Approval Date2005-01-14
Registered USA Implants18984
Estimated Active USA Implants1622
Normal Battery Depletions5423
US Market Release2005-04-08
CE Approval Date2005-01-14
Estimated WW Distribution30906
Normal Battery Depletions5518
Information

Malfunctions (USA)

Therapy Function Not Compromised 107
Battery 1
Electrical Component 15
Possible Early Battery Depletion 90
Other 1
Therapy Function Compromised 5
Electrical Component 4
Other 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 143
Battery 1
Electrical Component 36
Possible Early Battery Depletion 105
Other 1
Therapy Function Compromised 12
Battery 1
Electrical Component 10
Other 1
Information

Elective Replacement (ERI)

Battery voltage less than 2.62 V or Charge Time greater than 16 seconds.

Information

Charge Time

7304_CHRG
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050