D354DRM Protecta XT DR
Implantable Cardioverter Defibrillator (ICD)
D354DRM Protecta XT DR
Information

Device Survival Probability

D3xxDRx_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr at 147.0 mo                
% Excluding Normal Battery Depletion 100.0 99.9 99.9 99.9 99.9 99.8 99.7 99.7 99.6 99.6 99.6 99.6 99.6                
% Including Normal Battery Depletion 99.8 99.7 99.5 99.0 97.2 91.3 77.7 53.0 39.0 37.4 36.9 36.7 36.7                
#   54185 50301 46253 42262 37892 31014 20480 9398 5321 4618 3945 1133 266                
  • 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

Customer Communications For This Model

  • There are no communications for this model.
Information

Product Characteristics

Generator Type ICD
NBD Code DDE-DDDR
Max. Delivered Energy 35 J
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Connector Style DF4 DR Style
Serial Number Prefix PSD
Mass 73g
Volume 41cc
Waveform Biphasic
X-Ray ID PSI
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DF4 DR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 3.6 4.1 4.5 4.7
Quarterly 5.1 6.0 7.0 7.5
Semi-annual 5.7 7.0 8.3 9.0
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; 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 Release
CE Approval Date2010-07-15
Registered USA Implants1
Estimated Active USA Implants0
Normal Battery Depletions
US Market Release
CE Approval Date2010-07-15
Estimated WW Distribution15971
Normal Battery Depletions10
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 12
Battery 5
Electrical Component 6
Software/Firmware 1
Therapy Function Compromised 8
Battery 4
Electrical Component 3
Software/Firmware 1
Information

EOL 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 2.63V on 3 consecutive daily automatic measurements.

Information

Charge Time

D354DRx_CHRG
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Data as of November 20, 2024

www.medtronic.com/productperformance 1026050