6935 Sprint Quattro Secure
Defibrillation
6935 Sprint Quattro Secure
ALL
Information

Device Survival Probability


6935_SURV
    1 yr 2 yr 3 yr 4 yr            
% Survival 99.4 99.1 98.6 98.3            
#   1426 729 327 66            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2337
Cumulative Months of Follow-Up 42517
Number of Leads Active in Study 1744
Information 17

Qualifying Complications

Conductor Fracture 5
Failure to Capture 2
Failure to Sense 1
Lead Dislodgement 4
Oversensing 4
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 12
Failure to Capture 17
Failure to Sense 5
Impedance Out of Range 13
Insulation Breach 1
Lead Dislodgement 29
Oversensing 30
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants45404
Estimated Active USA Implants40763
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution87539
Information

USA Returned Product Analysis

Conductor Fracture 83
Insulation Breach 2
Crimp/Weld/Bond 0
Other 37
Information

WW Returned Product Analysis

Conductor Fracture 206
Insulation Breach 6
Crimp/Weld/Bond 0
Other 59
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, 2014

www.medtronic.com/productperformance 301050