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            
% Survival 99.7 99.5 99.4 99.4            
#   1551 1226 898 245            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1960
Cumulative Months of Follow-Up 58044
Number of Leads Active in Study 1225
Information 9

Qualifying Complications

Conductor Fracture 2
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 0
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 23
Conductor Fracture 9
Extra Cardiac Stimulation 10
Failure to Capture 71
Failure to Sense 20
Impedance Out of Range 19
Lead Dislodgement 128
Oversensing 44
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants87514
Estimated Active USA Implants79905
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution171582
Information

USA Returned Product Analysis

Conductor Fracture 49
Insulation Breach 5
Crimp/Weld/Bond 0
Other 11
Information

WW Returned Product Analysis

Conductor Fracture 119
Insulation Breach 6
Crimp/Weld/Bond 0
Other 13
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
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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 February 3, 2017

www.medtronic.com/productperformance 476050