DTPC2QQ Crome HF Quad
Cardiac Resynchronization Therapy - Defibrillation (CRT-Defib)
DTPC2QQ Crome HF Quad
Information

Device Survival Probability

COBALT_CROME_HF
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    1 yr at 15.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   1377 218                
  • 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 40 J
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Serial Number Prefix RTS
Mass 83 g
Volume 35.5 cc
Waveform Biphasic
X-Ray ID PLS
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Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.5 5.0 5.4 5.5
Quarterly 6.9 8.0 8.9 9.4
Semi-annual 8.0 9.4 10.7 11.4
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 1.5V; Ventricular Pulse Amplitude 2V; Atrial Impedance 500ohms; Ventricle Impedance 500ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm;Atrial Fib percentage of time 0%; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formationHide this content

Information

Distribution Data

US Market Release2020-04-23
CE Approval Date2019-12-18
Registered USA Implants529
Estimated Active USA Implants509
Normal Battery Depletions
US Market Release2020-04-23
CE Approval Date2019-12-18
Estimated WW Distribution835
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOS Indicator

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 or equal to 2.8 V on 3 consecutive daily automatic measurements.

Data as of October 11, 2021

www.medtronic.com/productperformance 826050