6947 Sprint Quattro Secure
Defibrillation
6947 Sprint Quattro Secure
ALL
Information

Device Survival Probability

6947_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr at 138.0 mo                  
% Survival 99.5 99.3 99.0 98.5 98.0 97.7 97.1 96.8 96.3 95.7 95.1 94.0                  
#   3207 2581 2077 1523 979 523 399 342 279 179 94 55                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3808
Cumulative Months of Follow-Up 167985
Number of Leads Active in Study 1538
Information 56

Qualifying Complications

Conductor Fracture 16
Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 6
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 20
Extra Cardiac Stimulation 2
Failure to Capture 75
Failure to Sense 30
Impedance Out of Range 55
Insulation Breach 4
Lead Dislodgement 114
Oversensing 124
Unspecified Clinical Failure 22
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants371089
Estimated Active USA Implants215338
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution575853
Information

USA Returned Product Analysis

Conductor Fracture 732
Insulation Breach 66
Crimp/Weld/Bond 4
Other 214
Information

WW Returned Product Analysis

Conductor Fracture 973
Insulation Breach 90
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
Hide this content

Data as of November 2, 2015

www.medtronic.com/productperformance 376051