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 at 66.0 mo        
% Survival 99.7 99.5 99.4 99.4 98.9 98.9        
#   1676 1383 1152 890 550 232        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2051
Cumulative Months of Follow-Up 79724
Number of Leads Active in Study 1041
Information 13

Qualifying Complications

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

US Acute Lead Observations

Cardiac Perforation 25
Conductor Fracture 9
Extra Cardiac Stimulation 10
Failure to Capture 84
Failure to Sense 31
Impedance Out of Range 23
Lead Dislodgement 170
Oversensing 51
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants106282
Estimated Active USA Implants96076
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution208959
Information

USA Returned Product Analysis

Conductor Fracture 99
Insulation Breach 9
Crimp/Weld/Bond 0
Other 18
Information

WW Returned Product Analysis

Conductor Fracture 195
Insulation Breach 12
Crimp/Weld/Bond 0
Other 21
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 October 12, 2018

www.medtronic.com/productperformance 626050