DDMD3D1 Primo
Implantable Cardioverter Defibrillator (ICD)
DDMD3D1 Primo
Information

Device Survival Probability

EVERA_DR_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 at 124.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.8 99.8 99.7 99.7 99.7 99.7                    
% Including Normal Battery Depletion 99.9 99.9 99.8 99.7 99.5 99.0 97.7 94.7 89.5 76.7 62.1                    
#   215979 193111 172133 146486 117228 88287 61023 36887 18488 4254 657                    
  • 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 ICD
NBD Code DDE-DDDR
Max. Delivered Energy 36 J
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Serial Number Prefix CWM
Mass 78 g
Volume 34 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 4.1 4.6 5.1 5.3
Quarterly 5.9 7.0 8.3 8.9
Semi-annual 6.2 7.6 9.0 9.7
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; Optivol ON; 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 Release2018-03-01
CE Approval Date2017-11-10
Registered USA Implants442
Estimated Active USA Implants391
Normal Battery Depletions
US Market Release2018-03-01
CE Approval Date2017-11-10
Estimated WW Distribution8329
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
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 2.73V on 3 consecutive daily automatic measurements.

Information

Charge Time

BLACKWELL_DR_CHRG
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Data as of April 30, 2024

www.medtronic.com/productperformance 1001052