6947 Sprint Quattro Secure
Defibrillation
6947 Sprint Quattro Secure
ALL
Information

Device Survival Probability

6947_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr                    
% Survival 99.4 99.2 98.8 98.4 97.9 97.4 96.7 96.4 95.8 95.4 94.2                    
#   2556 2060 1653 1168 648 466 386 333 265 141 54                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3259
Cumulative Months of Follow-Up 134902
Number of Leads Active in Study 1308
Information 49

Qualifying Complications

Conductor Fracture 13
Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 7
Insulation (not further defined) 3
Lead Dislodgement 4
Oversensing 14
Other 2
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 18
Extra Cardiac Stimulation 2
Failure to Capture 72
Failure to Sense 30
Impedance Out of Range 51
Insulation Breach 4
Lead Dislodgement 106
Oversensing 120
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants367372
Estimated Active USA Implants240975
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution491540
Information

USA Returned Product Analysis

Conductor Fracture 636
Insulation Breach 56
Crimp/Weld/Bond 4
Other 215
Information

WW Returned Product Analysis

Conductor Fracture 856
Insulation Breach 77
Crimp/Weld/Bond 4
Other 279
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 TDG
Lead Body Diameter 8.6 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050