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 at 102.0 mo  
% Survival 98.5 96.8 93.6 91.3 88.8 85.2 82.2 78.5 78.5  
#   773 638 537 442 354 277 158 67 53  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 923
Cumulative Months of Follow-Up 44616
Number of Leads Active in Study 237
Information 95

Qualifying Complications

Conductor Fracture 50
Failure to Capture 3
Failure to Sense 6
Impedance Out of Range 17
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 15
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 45
Failure to Capture 31
Failure to Sense 19
Impedance Out of Range 17
Insulation Breach 6
Lead Dislodgement 22
Oversensing 30
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186784
Estimated Active USA Implants65386
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution221024
Information

USA Returned Product Analysis

Conductor Fracture 7077
Insulation Breach 32
Crimp/Weld/Bond 3
Other 70
Information

WW Returned Product Analysis

Conductor Fracture 8227
Insulation Breach 37
Crimp/Weld/Bond 3
Other 104
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 February 9, 2015

www.medtronic.com/productperformance 351052