6947M Sprint Quattro Secure
6947M Sprint Quattro Secure

Device Survival Probability


    1 yr 2 yr 3 yr 4 yr 5 yr          
% Survival 99.7 99.5 99.4 99.4 98.7          
#   1639 1338 1101 764 271          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2019
Cumulative Months of Follow-Up 72498
Number of Leads Active in Study 1090
Information 12

Qualifying Complications

Conductor Fracture 5
Failure to Capture 4
Failure to Sense 2
Other 1

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 9
Extra Cardiac Stimulation 10
Failure to Capture 79
Failure to Sense 30
Impedance Out of Range 23
Lead Dislodgement 160
Oversensing 51

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants101512
Estimated Active USA Implants91988
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution198475

USA Returned Product Analysis

Conductor Fracture 81
Insulation Breach 9
Crimp/Weld/Bond 0
Other 16

WW Returned Product Analysis

Conductor Fracture 170
Insulation Breach 12
Crimp/Weld/Bond 0
Other 18

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
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 January 31, 2018

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