6947 Sprint Quattro Secure
Defibrillation
6947 Sprint Quattro Secure
ALL
Information

Device Survival Probability


6947_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 126 mo                    
% Survival 99.4 99.2 98.9 98.4 97.9 97.4 96.9 96.6 95.9 95.2 95.2                    
#   2353 1926 1525 904 574 452 368 304 209 99 69                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3064
Cumulative Months of Follow-Up 121574
Number of Leads Active in Study 1299
Information 44

Qualifying Complications

Conductor Fracture 10
Failure to Capture 1
Failure to Sense 2
Impedance Out of Range 7
Insulation (not further defined) 3
Lead Dislodgement 4
Oversensing 14
Other 1
Unspecified Clinical Failure 2
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 18
Extra Cardiac Stimulation 2
Failure to Capture 68
Failure to Sense 29
Impedance Out of Range 47
Insulation Breach 4
Lead Dislodgement 102
Oversensing 120
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants365223
Estimated Active USA Implants241483
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution485342
Information

USA Returned Product Analysis

Conductor Fracture 565
Insulation Breach 47
Crimp/Weld/Bond 4
Other 213
Information

WW Returned Product Analysis

Conductor Fracture 767
Insulation Breach 63
Crimp/Weld/Bond 4
Other 277
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
Hide this content

Data as of January 31, 2014

www.medtronic.com/productperformance 301050