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            
% Survival 99.6 99.4 99.0 98.6            
#   2958 1493 588 91            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5083
Cumulative Months of Follow-Up 87306
Number of Leads Active in Study 4010
Information 28

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 5
Failure to Capture 7
Failure to Sense 1
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 10
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 71
Conductor Fracture 4
Extra Cardiac Stimulation 10
Failure to Capture 123
Failure to Sense 23
Impedance Out of Range 40
Insulation Breach 1
Lead Dislodgement 210
Oversensing 89
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants144111
Estimated Active USA Implants136200
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution308386
Information

USA Returned Product Analysis

Conductor Fracture 126
Insulation Breach 2
Crimp/Weld/Bond 0
Other 15
Information

WW Returned Product Analysis

Conductor Fracture 243
Insulation Breach 7
Crimp/Weld/Bond 0
Other 29
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 July 31, 2017

www.medtronic.com/productperformance 501050