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 99.5 99.3 99.0 98.5 98.0 97.5 96.9 96.6 96.1 95.7 94.9                    
#   2924 2347 1857 1324 773 476 390 338 276 160 74                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3608
Cumulative Months of Follow-Up 151880
Number of Leads Active in Study 1528
Information 51

Qualifying Complications

Conductor Fracture 14
Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 8
Insulation (not further defined) 3
Lead Dislodgement 4
Oversensing 15
Other 1
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 27
Conductor Fracture 19
Extra Cardiac Stimulation 2
Failure to Capture 74
Failure to Sense 30
Impedance Out of Range 54
Insulation Breach 4
Lead Dislodgement 108
Oversensing 119
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants369050
Estimated Active USA Implants235704
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution496038
Information

USA Returned Product Analysis

Conductor Fracture 673
Insulation Breach 62
Crimp/Weld/Bond 4
Other 215
Information

WW Returned Product Analysis

Conductor Fracture 904
Insulation Breach 85
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 February 9, 2015

www.medtronic.com/productperformance 351052