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 at 150.0 mo                
% Survival 99.5 99.3 99.0 98.7 98.2 97.9 97.3 97.1 96.6 96.1 95.7 95.1 95.1                
#   3427 2896 2338 1864 1331 848 468 358 289 203 144 71 51                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4049
Cumulative Months of Follow-Up 194186
Number of Leads Active in Study 1473
Information 61

Qualifying Complications

Conductor Fracture 20
Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 7
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 15
Other 3
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 33
Impedance Out of Range 55
Insulation Breach 4
Lead Dislodgement 115
Oversensing 125
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants372231
Estimated Active USA Implants210448
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution583642
Information

USA Returned Product Analysis

Conductor Fracture 803
Insulation Breach 75
Crimp/Weld/Bond 4
Other 215
Information

WW Returned Product Analysis

Conductor Fracture 1060
Insulation Breach 100
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
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 August 3, 2016

www.medtronic.com/productperformance 451050