6945 Sprint
Defibrillation
6945 Sprint
ALL
Information

Device Survival Probability

6945_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 99.4 98.6 98.1 97.5 96.5 95.7 95.0 93.9 92.5 91.5 90.3 89.6 88.9 87.0 85.9            
#   1024 832 658 521 403 313 273 229 186 155 133 118 94 64 53            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1199
Cumulative Months of Follow-Up 67766
Number of Leads Active in Study 81
Information 45

Qualifying Complications

Conductor Fracture 11
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 4
Impedance Out of Range 7
Oversensing 19
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 1
Insulation Breach 2
Lead Dislodgement 4
Oversensing 8
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1997-09-26
CE Approval Date
Registered USA Implants42695
Estimated Active USA Implants9565
US Market Release1997-09-26
CE Approval Date
Estimated WW Distribution52530
Information

USA Returned Product Analysis

Conductor Fracture 147
Insulation Breach 46
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 175
Insulation Breach 56
Crimp/Weld/Bond 1
Other 14
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 Integrated Bipolar/Two Coils
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Serial Number Prefix TDA
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of February 3, 2017

www.medtronic.com/productperformance 476050