DTMA1Q1 Claria MRI
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
DTMA1Q1 Claria MRI
Information

Device Survival Probability

AMPLIA_CLARIA_COMPIA_QUAD_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 92.0 mo    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.9 99.9 99.9    
% Including Normal Battery Depletion 100.0 99.9 99.6 98.4 96.0 90.7 79.8 59.3    
#   112334 94166 77983 58748 38332 20535 6405 321    
  • 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

Product Characteristics

Generator Type CRT-Defib
NBD Code DDE-DDDR
Max. Delivered Energy 36 J
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Serial Number Prefix RPS
Mass 82 g
Volume 36 cc
Waveform Biphasic
X-Ray ID PFZ
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Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.6 4.3 4.9 5.3
Quarterly 4.9 6.3 7.8 8.8
Semi-annual 5.2 6.6 8.5 9.6
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; Integrated 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

Distribution Data

US Market Release2016-12-05
CE Approval Date
Registered USA Implants13144
Estimated Active USA Implants10089
Normal Battery Depletions261
US Market Release2016-12-05
CE Approval Date
Estimated WW Distribution20208
Normal Battery Depletions261
Information

Malfunctions (USA)

Therapy Function Not Compromised 4
Battery 1
Electrical Interconnect 1
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 7
Battery 2
Electrical Component 2
Electrical Interconnect 1
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 0
Information

EOS Indication

From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Recommended Replacement (RRT)

Battery voltage less than 2.73V on 3 consecutive daily automatic measurements.

Information

Charge Time

BLACKWELL_CRT-D_CHRG
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Data as of April 30, 2024

www.medtronic.com/productperformance 1001052