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 14 yr              
% Survival 99.5 99.3 99.0 98.7 98.2 98.0 97.6 97.2 96.6 95.8 95.5 94.6 94.6 93.9              
#   3715 3173 2684 2265 1786 1377 944 635 353 217 158 103 89 51              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4361
Cumulative Months of Follow-Up 235702
Number of Leads Active in Study 1207
Information 75

Qualifying Complications

Conductor Fracture 28
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 11
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 17
Other 1
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 28
Conductor Fracture 23
Extra Cardiac Stimulation 2
Failure to Capture 79
Failure to Sense 35
Impedance Out of Range 59
Insulation Breach 4
Lead Dislodgement 121
Oversensing 127
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants374816
Estimated Active USA Implants202336
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution597872
Information

USA Returned Product Analysis

Conductor Fracture 1025
Insulation Breach 90
Crimp/Weld/Bond 4
Other 214
Information

WW Returned Product Analysis

Conductor Fracture 1322
Insulation Breach 116
Crimp/Weld/Bond 4
Other 278
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 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 October 12, 2018

www.medtronic.com/productperformance 626050