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 9 yr  
% Survival 99.6 99.5 99.2 98.9 98.6 98.0 97.6 97.4 97.0  
#   6401 5132 4191 3350 2673 1810 1006 439 132  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 8680
Cumulative Months of Follow-Up 345426
Number of Leads Active in Study 4489
Information 98

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 37
Extra Cardiac Stimulation 1
Failure to Capture 19
Failure to Sense 1
Impedance Out of Range 9
Insulation (not further defined) 3
Lead Dislodgement 18
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 167
Conductor Fracture 19
Extra Cardiac Stimulation 30
Failure to Capture 381
Failure to Sense 129
Impedance Out of Range 110
Insulation Breach 3
Lead Dislodgement 596
Oversensing 308
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants353907
Estimated Active USA Implants289642
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution808176
Information

USA Returned Product Analysis

Conductor Fracture 683
Insulation Breach 33
Crimp/Weld/Bond 1
Other 94
Information

WW Returned Product Analysis

Conductor Fracture 1157
Insulation Breach 50
Crimp/Weld/Bond 2
Other 146
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 May 10, 2023

www.medtronic.com/productperformance 926050