DTMB2D4 Amplia MRI
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
DTMB2D4 Amplia MRI
Information

Device Survival Probability

AMPLIA_CLARIA_COMPIA_SURV
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    1 yr at 18.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   716 106                
  • 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.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type CRT-Defib
NBD Code DDE-DDDR
Max. Delivered Energy 36 J
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Connector Style DF4 CRT-D Style
Serial Number Prefix RPK
Mass 80 g
Volume 35 cc
Waveform Biphasic
X-Ray ID PFZ
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DF4 CRT-D Style
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

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

Distribution Data

US Market Release
CE Approval Date2016-02-19
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2016-02-19
Estimated WW Distribution1934
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
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 July 31, 2017

www.medtronic.com/productperformance 501050