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 at 174.0 mo            
% Survival 99.5 99.3 99.0 98.7 98.2 98.0 97.6 97.3 96.8 96.0 95.7 94.9 94.9 94.3 93.5            
#   3807 3251 2765 2329 1929 1485 1125 811 530 258 165 108 90 68 52            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4436
Cumulative Months of Follow-Up 250575
Number of Leads Active in Study 1105
Information 81

Qualifying Complications

Conductor Fracture 28
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 12
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 18
Other 2
Unspecified Clinical Failure 3
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 24
Extra Cardiac Stimulation 2
Failure to Capture 81
Failure to Sense 34
Impedance Out of Range 59
Insulation Breach 4
Lead Dislodgement 122
Oversensing 140
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants374694
Estimated Active USA Implants195023
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution602294
Information

USA Returned Product Analysis

Conductor Fracture 1147
Insulation Breach 94
Crimp/Weld/Bond 4
Other 188
Information

WW Returned Product Analysis

Conductor Fracture 1455
Insulation Breach 123
Crimp/Weld/Bond 4
Other 232
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 November 8, 2019

www.medtronic.com/productperformance 726050