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 5 yr 6 yr        
% Survival 99.7 99.5 99.3 99.3 99.0 99.0        
#   1693 1408 1186 937 685 180        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2078
Cumulative Months of Follow-Up 85063
Number of Leads Active in Study 999
Information 14

Qualifying Complications

Conductor Fracture 6
Failure to Capture 4
Failure to Sense 2
Lead Dislodgement 1
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 9
Extra Cardiac Stimulation 10
Failure to Capture 89
Failure to Sense 31
Impedance Out of Range 25
Lead Dislodgement 180
Oversensing 63
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants110628
Estimated Active USA Implants99750
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution218390
Information

USA Returned Product Analysis

Conductor Fracture 126
Insulation Breach 10
Crimp/Weld/Bond 0
Other 21
Information

WW Returned Product Analysis

Conductor Fracture 230
Insulation Breach 13
Crimp/Weld/Bond 0
Other 24
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 April 11, 2019

www.medtronic.com/productperformance 651050