6949 Sprint Fidelis
Defibrillation
6949 Sprint Fidelis
ALL
Information

Device Survival Probability

6949_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 98.5 96.7 93.6 91.3 88.7 84.9 81.7 78.5    
#   728 613 515 426 340 255 127 55    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 893
Cumulative Months of Follow-Up 42048
Number of Leads Active in Study 230
Information 91

Qualifying Complications

Conductor Fracture 47
Failure to Capture 3
Failure to Sense 5
Impedance Out of Range 16
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 15
Other 2
Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 44
Failure to Capture 32
Failure to Sense 19
Impedance Out of Range 17
Insulation Breach 6
Lead Dislodgement 23
Oversensing 31
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186780
Estimated Active USA Implants69359
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution220965
Information

USA Returned Product Analysis

Conductor Fracture 6920
Insulation Breach 31
Crimp/Weld/Bond 3
Other 69
Information

WW Returned Product Analysis

Conductor Fracture 8062
Insulation Breach 36
Crimp/Weld/Bond 3
Other 103
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 LFJ
Lead Body Diameter 6.6 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 August 3, 2014

www.medtronic.com/productperformance 326050