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 95.9 95.6 94.8 94.8 94.1              
#   3764 3216 2716 2304 1884 1425 1040 724 425 237 159 103 89 63              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4394
Cumulative Months of Follow-Up 243050
Number of Leads Active in Study 1161
Information 79

Qualifying Complications

Conductor Fracture 28
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 12
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 17
Other 2
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 24
Extra Cardiac Stimulation 2
Failure to Capture 79
Failure to Sense 34
Impedance Out of Range 58
Insulation Breach 4
Lead Dislodgement 122
Oversensing 137
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants375195
Estimated Active USA Implants201443
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution600010
Information

USA Returned Product Analysis

Conductor Fracture 1089
Insulation Breach 93
Crimp/Weld/Bond 4
Other 187
Information

WW Returned Product Analysis

Conductor Fracture 1395
Insulation Breach 120
Crimp/Weld/Bond 4
Other 231
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 April 11, 2019

www.medtronic.com/productperformance 651050