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 15 yr 16 yr 17 yr        
% Survival 99.5 99.3 99.0 98.7 98.2 97.9 97.5 97.0 96.6 96.0 95.6 95.1 95.1 94.6 93.9 91.0 91.0        
#   3275 2879 2525 2230 1990 1739 1478 1285 1054 783 515 295 211 170 135 101 59        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4475
Cumulative Months of Follow-Up 269478
Number of Leads Active in Study 912
Information 92

Qualifying Complications

Conductor Fracture 34
Failure to Capture 7
Failure to Sense 2
Impedance Out of Range 13
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 19
Other 4
Unspecified Clinical Failure 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 26
Extra Cardiac Stimulation 2
Failure to Capture 82
Failure to Sense 34
Impedance Out of Range 61
Insulation Breach 4
Lead Dislodgement 124
Oversensing 140
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants376124
Estimated Active USA Implants130778
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution612933
Information

USA Returned Product Analysis

Conductor Fracture 1306
Insulation Breach 99
Crimp/Weld/Bond 4
Other 193
Information

WW Returned Product Analysis

Conductor Fracture 1629
Insulation Breach 128
Crimp/Weld/Bond 4
Other 237
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 11, 2021

www.medtronic.com/productperformance 826050