DVFB1D4 Visia MRI AF
Implantable Cardioverter Defibrillator (ICD)
DVFB1D4 Visia MRI AF
Information

Device Survival Probability

VISIA_AF_SURV
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    1 yr at 17.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   3993 129                
  • 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

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type ICD
NBD Code VVE-VVIR
Max. Delivered Energy 36 J
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Connector Style DF4 VR Style
Serial Number Prefix PKX
Mass 77 g
Volume 33 cc
Waveform Biphasic
X-Ray ID PFZ
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DF4 VR Style
Information

Estimated Longevity

Charging Frequency 100% Pacing 50% Pacing 15% Pacing 100% Sensing
Monthly 4.9 5.3 5.7 5.8
Quarterly 7.8 8.8 9.7 10.1
Semi-annual 8.5 9.7 10.7 11.3
Footnote

Longevity estimates based on the following device usage. Pacing Mode VVI; Ventricular Lower Pacing Rate 60ppm; Ventricular Pulse Width 0.4ms; Ventricular Pulse Amplitude 3V; Ventricle Impedance 510ohms; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; 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 Release2016-01-19
CE Approval Date
Registered USA Implants13597
Estimated Active USA Implants13334
Normal Battery Depletions1
US Market Release2016-01-19
CE Approval Date
Estimated WW Distribution15855
Normal Battery Depletions1
Information

Malfunctions (USA)

Therapy Function Not Compromised 2
Electrical Component 2
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Electrical Component 2
Therapy Function Compromised 0
Information

Recommended Replacement (RRT)

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

Information

Charge Time

BLACKWELL_VR_CHRG
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050