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        
% Survival 99.6 99.5 99.2 99.0 98.9 98.0        
#   4709 3565 2193 1110 432 69        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 6331
Cumulative Months of Follow-Up 179033
Number of Leads Active in Study 4140
Information 45

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 11
Extra Cardiac Stimulation 1
Failure to Capture 10
Failure to Sense 1
Impedance Out of Range 3
Insulation (not further defined) 2
Lead Dislodgement 13
Oversensing 2
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 104
Conductor Fracture 7
Extra Cardiac Stimulation 19
Failure to Capture 200
Failure to Sense 57
Impedance Out of Range 55
Insulation Breach 1
Lead Dislodgement 337
Oversensing 167
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants221049
Estimated Active USA Implants207090
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution479501
Information

USA Returned Product Analysis

Conductor Fracture 318
Insulation Breach 13
Crimp/Weld/Bond 0
Other 48
Information

WW Returned Product Analysis

Conductor Fracture 562
Insulation Breach 23
Crimp/Weld/Bond 0
Other 78
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 November 8, 2019

www.medtronic.com/productperformance 726050