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 at 42.0 mo            
% Survival 99.6 99.4 99.1 99.1            
#   2280 997 276 89            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4616
Cumulative Months of Follow-Up 63880
Number of Leads Active in Study 3804
Information 19

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 4
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 7
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

US Acute Lead Observations

Cardiac Perforation 50
Conductor Fracture 3
Extra Cardiac Stimulation 8
Failure to Capture 105
Failure to Sense 17
Impedance Out of Range 29
Insulation Breach 1
Lead Dislodgement 152
Oversensing 75
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants114336
Estimated Active USA Implants108393
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution246452
Information

USA Returned Product Analysis

Conductor Fracture 84
Insulation Breach 2
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 157
Insulation Breach 4
Crimp/Weld/Bond 0
Other 20
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 February 3, 2017

www.medtronic.com/productperformance 476050