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 99.1 98.7 98.3 98.0 97.4 97.1 96.6 96.1 95.7 94.7 94.7                
#   3506 2977 2470 1945 1491 1004 577 369 294 205 150 81 50                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4131
Cumulative Months of Follow-Up 204747
Number of Leads Active in Study 1419
Information 64

Qualifying Complications

Conductor Fracture 22
Failure to Capture 3
Failure to Sense 2
Impedance Out of Range 10
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 15
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 28
Conductor Fracture 21
Extra Cardiac Stimulation 2
Failure to Capture 77
Failure to Sense 34
Impedance Out of Range 56
Insulation Breach 4
Lead Dislodgement 115
Oversensing 126
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants373104
Estimated Active USA Implants207968
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution587676
Information

USA Returned Product Analysis

Conductor Fracture 850
Insulation Breach 79
Crimp/Weld/Bond 4
Other 215
Information

WW Returned Product Analysis

Conductor Fracture 1119
Insulation Breach 104
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 3, 2017

www.medtronic.com/productperformance 476050