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 at 78.0 mo      
% Survival 99.6 99.5 99.2 98.9 98.6 98.0 98.0      
#   4933 3864 2650 1459 685 181 61      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 6507
Cumulative Months of Follow-Up 200903
Number of Leads Active in Study 4065
Information 54

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 15
Extra Cardiac Stimulation 1
Failure to Capture 12
Failure to Sense 1
Impedance Out of Range 4
Insulation (not further defined) 2
Lead Dislodgement 13
Oversensing 2
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 113
Conductor Fracture 8
Extra Cardiac Stimulation 21
Failure to Capture 217
Failure to Sense 66
Impedance Out of Range 60
Insulation Breach 2
Lead Dislodgement 375
Oversensing 186
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants236743
Estimated Active USA Implants220286
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution512444
Information

USA Returned Product Analysis

Conductor Fracture 350
Insulation Breach 16
Crimp/Weld/Bond 0
Other 59
Information

WW Returned Product Analysis

Conductor Fracture 615
Insulation Breach 26
Crimp/Weld/Bond 0
Other 92
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 April 10, 2020

www.medtronic.com/productperformance 751050