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 at 90.0 mo    
% Survival 99.4 99.2 98.9 98.6 98.4 97.9 96.9 95.8    
#   2205 1771 1402 1056 678 369 175 81    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2606
Cumulative Months of Follow-Up 106913
Number of Leads Active in Study 1046
Information 37

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 14
Extra Cardiac Stimulation 1
Failure to Capture 3
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 7
Oversensing 6
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 21
Conductor Fracture 2
Failure to Capture 23
Failure to Sense 8
Impedance Out of Range 17
Insulation Breach 1
Lead Dislodgement 52
Oversensing 51
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants57947
Estimated Active USA Implants46331
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution160138
Information

USA Returned Product Analysis

Conductor Fracture 255
Insulation Breach 9
Crimp/Weld/Bond 0
Other 40
Information

WW Returned Product Analysis

Conductor Fracture 558
Insulation Breach 23
Crimp/Weld/Bond 0
Other 66
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 January 31, 2018

www.medtronic.com/productperformance 601051