6947M Sprint Quattro Secure
Defibrillation
6947M Sprint Quattro Secure
ALL
Information

Device Survival Probability

6947M_SURV
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    1 yr 2 yr 3 yr 4 yr at 54.0 mo          
% Survival 99.7 99.5 99.4 99.4 99.4          
#   1596 1286 1046 583 259          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1997
Cumulative Months of Follow-Up 66021
Number of Leads Active in Study 1157
Information 10

Qualifying Complications

Conductor Fracture 3
Failure to Capture 4
Failure to Sense 2
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 9
Extra Cardiac Stimulation 10
Failure to Capture 78
Failure to Sense 24
Impedance Out of Range 21
Lead Dislodgement 151
Oversensing 50
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants96682
Estimated Active USA Implants87734
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution189329
Information

USA Returned Product Analysis

Conductor Fracture 68
Insulation Breach 6
Crimp/Weld/Bond 0
Other 15
Information

WW Returned Product Analysis

Conductor Fracture 150
Insulation Breach 9
Crimp/Weld/Bond 0
Other 17
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/Two Coils
More
Serial Number Prefix TDK
Lead Body Diameter 8.6 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style DF4-LLHH
High Voltage Connector DF4-LLHH
Steroid Yes
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050