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 6 yr 7 yr 8 yr    
% Survival 99.6 99.5 99.2 98.9 98.4 97.7 97.5 97.5    
#   5712 4615 3625 2768 1746 867 353 52    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 7355
Cumulative Months of Follow-Up 274486
Number of Leads Active in Study 4056
Information 82

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 27
Extra Cardiac Stimulation 1
Failure to Capture 16
Failure to Sense 1
Impedance Out of Range 7
Insulation (not further defined) 3
Lead Dislodgement 17
Oversensing 5
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 141
Conductor Fracture 16
Extra Cardiac Stimulation 26
Failure to Capture 291
Failure to Sense 91
Impedance Out of Range 85
Insulation Breach 2
Lead Dislodgement 506
Oversensing 259
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants299768
Estimated Active USA Implants242583
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution668151
Information

USA Returned Product Analysis

Conductor Fracture 521
Insulation Breach 28
Crimp/Weld/Bond 1
Other 76
Information

WW Returned Product Analysis

Conductor Fracture 891
Insulation Breach 44
Crimp/Weld/Bond 1
Other 117
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 December 16, 2021

www.medtronic.com/productperformance 851050