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 12 yr 13 yr                
% Survival 99.5 99.3 99.0 98.7 98.2 98.0 97.5 97.0 96.4 95.6 95.3 94.4 94.4                
#   3596 3057 2585 2074 1641 1162 730 415 301 210 152 102 68                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4252
Cumulative Months of Follow-Up 217508
Number of Leads Active in Study 1329
Information 70

Qualifying Complications

Conductor Fracture 24
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 11
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 16
Other 1
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 28
Conductor Fracture 23
Extra Cardiac Stimulation 2
Failure to Capture 77
Failure to Sense 34
Impedance Out of Range 57
Insulation Breach 4
Lead Dislodgement 119
Oversensing 127
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants373927
Estimated Active USA Implants204478
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution592396
Information

USA Returned Product Analysis

Conductor Fracture 939
Insulation Breach 82
Crimp/Weld/Bond 4
Other 216
Information

WW Returned Product Analysis

Conductor Fracture 1222
Insulation Breach 107
Crimp/Weld/Bond 4
Other 280
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 July 31, 2017

www.medtronic.com/productperformance 501050