7299 InSync Sentry
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
7299 InSync Sentry
Information

Device Survival Probability

7299_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 74.0 mo      
% Excluding Normal Battery Depletion 100.0 99.9 99.7 99.2 99.0 98.8 98.8      
% Including Normal Battery Depletion 99.1 97.3 90.7 71.5 28.1 2.9 1.3      
#   27077 23696 19199 12912 4471 299 120      
  • 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 PRK
Mass 78 g
Volume 40 cc
Waveform Biphasic
X-Ray ID PRK
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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 Date
Registered USA Implants31184
Estimated Active USA Implants2033
Normal Battery Depletions9899
US Market Release2005-04-08
CE Approval Date
Estimated WW Distribution31736
Normal Battery Depletions9905
Information

Malfunctions (USA)

Therapy Function Not Compromised 168
Electrical Component 18
Possible Early Battery Depletion 147
Software/Firmware 2
Other 1
Therapy Function Compromised 10
Electrical Component 10
Information

Malfunctions (WW)

Therapy Function Not Compromised 193
Electrical Component 39
Electrical Interconnect 3
Possible Early Battery Depletion 148
Software/Firmware 2
Other 1
Therapy Function Compromised 11
Electrical Component 11
Information

Elective Replacement (ERI)

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

Information

Charge Time

7299_CHRG
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050