6931 Sprint Fidelis
Defibrillation
6931 Sprint Fidelis
ALL
Information

Device Survival Probability

6931_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 78.0 mo      
% Survival 98.2 96.2 93.1 88.2 81.7 73.3 73.3      
#   262 231 201 160 130 93 67      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 296
Cumulative Months of Follow-Up 15151
Number of Leads Active in Study 50
Information 54

Qualifying Complications

Conductor Fracture 32
Failure to Capture 3
Failure to Sense 1
Impedance Out of Range 9
Lead Dislodgement 2
Oversensing 7
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 1
Failure to Sense 1
Lead Dislodgement 1
Oversensing 3
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants8080
Estimated Active USA Implants3120
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution19950
Information

USA Returned Product Analysis

Conductor Fracture 574
Insulation Breach 1
Crimp/Weld/Bond 0
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 1643
Insulation Breach 3
Crimp/Weld/Bond 0
Other 18
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/One Coil
More
Serial Number Prefix LFL
Lead Body Diameter 6.6 FR
Insulation Silicone with Polyurethan 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