6935 Sprint Quattro Secure S
Defibrillation
6935 Sprint Quattro Secure S
ALL
Information

Device Survival Probability

6935_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
% Survival 99.5 99.2 98.9 98.6 98.4 98.0 97.3 96.6 95.0 95.0
#   2274 1865 1516 1219 1029 874 652 383 220 78

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2760
Cumulative Months of Follow-Up 135868
Number of Leads Active in Study 864
Information 53

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 20
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 7
Lead Dislodgement 7
Oversensing 7
Other 2
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 4
Extra Cardiac Stimulation 1
Failure to Capture 27
Failure to Sense 12
Impedance Out of Range 26
Insulation Breach 1
Lead Dislodgement 60
Oversensing 60
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants62149
Estimated Active USA Implants46413
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution179330
Information

USA Returned Product Analysis

Conductor Fracture 371
Insulation Breach 12
Crimp/Weld/Bond 0
Other 41
Information

WW Returned Product Analysis

Conductor Fracture 733
Insulation Breach 29
Crimp/Weld/Bond 0
Other 73
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/One Coil
More
Serial Number Prefix TAU
Lead Body Diameter 8,2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of October 29, 2020

www.medtronic.com/productperformance 776050