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 at 54.0 mo          
% Survival 99.5 99.4 98.9 98.5 98.5          
#   3544 1945 906 240 77          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5369
Cumulative Months of Follow-Up 108397
Number of Leads Active in Study 3996
Information 37

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 9
Failure to Capture 8
Failure to Sense 1
Impedance Out of Range 3
Insulation (not further defined) 1
Lead Dislodgement 12
Oversensing 1
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 78
Conductor Fracture 6
Extra Cardiac Stimulation 11
Failure to Capture 136
Failure to Sense 33
Impedance Out of Range 43
Insulation Breach 1
Lead Dislodgement 234
Oversensing 104
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants160934
Estimated Active USA Implants152029
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution343038
Information

USA Returned Product Analysis

Conductor Fracture 158
Insulation Breach 4
Crimp/Weld/Bond 0
Other 17
Information

WW Returned Product Analysis

Conductor Fracture 307
Insulation Breach 9
Crimp/Weld/Bond 0
Other 31
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 January 31, 2018

www.medtronic.com/productperformance 601051