6935 Sprint Quattro Secure S
Defibrillation
6935 Sprint Quattro Secure S
ALL
Information

Device Survival Probability

6935_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 102.0 mo  
% Survival 99.4 99.2 98.9 98.6 98.4 98.0 97.1 96.1 95.5  
#   2264 1830 1457 1131 888 571 310 135 75  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2669
Cumulative Months of Follow-Up 118629
Number of Leads Active in Study 954
Information 44

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 17
Extra Cardiac Stimulation 1
Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 5
Lead Dislodgement 7
Oversensing 6
Other 1
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Cardiac Perforation 22
Conductor Fracture 2
Failure to Capture 24
Failure to Sense 8
Impedance Out of Range 18
Insulation Breach 1
Lead Dislodgement 56
Oversensing 57
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants59666
Estimated Active USA Implants47374
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution168448
Information

USA Returned Product Analysis

Conductor Fracture 312
Insulation Breach 9
Crimp/Weld/Bond 0
Other 41
Information

WW Returned Product Analysis

Conductor Fracture 652
Insulation Breach 25
Crimp/Weld/Bond 0
Other 69
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 TAU
Lead Body Diameter 8,2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of April 11, 2019

www.medtronic.com/productperformance 651050