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 at 198.0 mo        
% Survival 99.5 99.3 99.0 98.7 98.2 97.9 97.5 97.0 96.6 96.0 95.6 95.0 95.0 94.4 93.7 90.5 90.5        
#   3273 2875 2519 2223 1976 1728 1456 1240 976 699 436 256 197 166 132 84 64        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4458
Cumulative Months of Follow-Up 263968
Number of Leads Active in Study 965
Information 91

Qualifying Complications

Conductor Fracture 33
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 59
Insulation Breach 4
Lead Dislodgement 123
Oversensing 140
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants375413
Estimated Active USA Implants185409
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution604910
Information

USA Returned Product Analysis

Conductor Fracture 1238
Insulation Breach 98
Crimp/Weld/Bond 4
Other 190
Information

WW Returned Product Analysis

Conductor Fracture 1553
Insulation Breach 126
Crimp/Weld/Bond 4
Other 234
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 October 29, 2020

www.medtronic.com/productperformance 776050