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

Device Survival Probability

6935M_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.6 99.5 99.1 98.9 98.7 97.7        
#   4482 3071 1700 781 226 83        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5914
Cumulative Months of Follow-Up 154758
Number of Leads Active in Study 3967
Information 42

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 10
Failure to Capture 10
Failure to Sense 1
Impedance Out of Range 3
Insulation (not further defined) 2
Lead Dislodgement 12
Oversensing 2
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 93
Conductor Fracture 7
Extra Cardiac Stimulation 15
Failure to Capture 170
Failure to Sense 47
Impedance Out of Range 49
Insulation Breach 1
Lead Dislodgement 291
Oversensing 147
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants198468
Estimated Active USA Implants187121
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution428349
Information

USA Returned Product Analysis

Conductor Fracture 261
Insulation Breach 11
Crimp/Weld/Bond 0
Other 35
Information

WW Returned Product Analysis

Conductor Fracture 480
Insulation Breach 19
Crimp/Weld/Bond 0
Other 57
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 TDL
Lead Body Diameter 2.8 mm (8.4 Fr)
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style DF4-LLHO
High Voltage Connector DF4-LLHO
Steroid Yes
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Data as of April 11, 2019

www.medtronic.com/productperformance 651050