6935 Sprint Quattro Secure
Defibrillation
6935 Sprint Quattro Secure
ALL
Information

Device Survival Probability

6935_SURV
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    1 yr 2 yr 3 yr 4 yr at 54.0 mo          
% Survival 99.5 99.2 98.9 98.1 98.1          
#   1689 980 479 151 53          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2311
Cumulative Months of Follow-Up 52846
Number of Leads Active in Study 1590
Information 18

Qualifying Complications

Conductor Fracture 6
Failure to Capture 1
Failure to Sense 1
Lead Dislodgement 5
Oversensing 3
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 13
Failure to Capture 18
Failure to Sense 5
Impedance Out of Range 13
Insulation Breach 1
Lead Dislodgement 31
Oversensing 36
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants47773
Estimated Active USA Implants42723
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution93135
Information

USA Returned Product Analysis

Conductor Fracture 109
Insulation Breach 4
Crimp/Weld/Bond 0
Other 37
Information

WW Returned Product Analysis

Conductor Fracture 266
Insulation Breach 9
Crimp/Weld/Bond 0
Other 60
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 August 3, 2014

www.medtronic.com/productperformance 326050