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    
% Survival 99.4 99.2 98.9 98.6 98.4 98.0 96.9 96.1    
#   2242 1806 1441 1108 801 484 249 84    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2644
Cumulative Months of Follow-Up 113636
Number of Leads Active in Study 974
Information 39

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 15
Extra Cardiac Stimulation 1
Failure to Capture 4
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 24
Failure to Sense 8
Impedance Out of Range 18
Insulation Breach 1
Lead Dislodgement 54
Oversensing 51
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants58809
Estimated Active USA Implants46829
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution163918
Information

USA Returned Product Analysis

Conductor Fracture 279
Insulation Breach 9
Crimp/Weld/Bond 0
Other 40
Information

WW Returned Product Analysis

Conductor Fracture 598
Insulation Breach 24
Crimp/Weld/Bond 0
Other 67
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 October 12, 2018

www.medtronic.com/productperformance 626050