6930 Sprint Fidelis
Defibrillation
6930 Sprint Fidelis
ALL
Information

Device Survival Probability

6930_SURV
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    at 0.0 mo                  
% Survival 100.0                  
#   0                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4
Cumulative Months of Follow-Up 203
Number of Leads Active in Study 2
Information

Qualifying Complications

Information

US Acute Lead Observations

Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants354
Estimated Active USA Implants165
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution1666
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 101
Insulation Breach 0
Crimp/Weld/Bond 0
Other 1
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/One Coil
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Serial Number Prefix LFK
Lead Body Diameter 6.6 FR
Insulation Silcone 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