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 at 78.0 mo      
% Survival 99.4 99.2 98.9 98.5 98.2 97.6 97.0      
#   2143 1704 1281 803 426 197 108      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2529
Cumulative Months of Follow-Up 93525
Number of Leads Active in Study 1171
Information 34

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 13
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 1
Impedance Out of Range 2
Lead Dislodgement 7
Oversensing 6
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 21
Conductor Fracture 1
Failure to Capture 20
Failure to Sense 8
Impedance Out of Range 17
Insulation Breach 1
Lead Dislodgement 42
Oversensing 49
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants55655
Estimated Active USA Implants45235
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution151135
Information

USA Returned Product Analysis

Conductor Fracture 213
Insulation Breach 8
Crimp/Weld/Bond 0
Other 40
Information

WW Returned Product Analysis

Conductor Fracture 474
Insulation Breach 19
Crimp/Weld/Bond 0
Other 64
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 February 3, 2017

www.medtronic.com/productperformance 476050