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 9 yr  
% Survival 99.4 99.2 99.0 98.6 98.5 98.0 97.3 96.6 95.0  
#   2309 1856 1479 1153 930 687 416 205 71  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2712
Cumulative Months of Follow-Up 124683
Number of Leads Active in Study 918
Information 46

Qualifying Complications

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

US Acute Lead Observations

Cardiac Perforation 24
Conductor Fracture 2
Extra Cardiac Stimulation 1
Failure to Capture 27
Failure to Sense 9
Impedance Out of Range 24
Insulation Breach 1
Lead Dislodgement 57
Oversensing 61
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants60635
Estimated Active USA Implants47415
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution173235
Information

USA Returned Product Analysis

Conductor Fracture 339
Insulation Breach 11
Crimp/Weld/Bond 0
Other 41
Information

WW Returned Product Analysis

Conductor Fracture 690
Insulation Breach 28
Crimp/Weld/Bond 0
Other 70
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 November 8, 2019

www.medtronic.com/productperformance 726050