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 9 yr 10 yr at 126.0 mo                    
% Survival 98.5 96.5 93.4 90.9 88.4 84.8 81.9 79.7 78.9 77.6 73.9                    
#   842 724 614 519 408 309 212 146 93 65 54                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 975
Cumulative Months of Follow-Up 53624
Number of Leads Active in Study 108
Information 120

Qualifying Complications

Conductor Fracture 68
Failure to Capture 5
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 18
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 19
Insulation Breach 5
Lead Dislodgement 22
Oversensing 32
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186698
Estimated Active USA Implants46120
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233864
Information

USA Returned Product Analysis

Conductor Fracture 7719
Insulation Breach 37
Crimp/Weld/Bond 3
Other 94
Information

WW Returned Product Analysis

Conductor Fracture 8912
Insulation Breach 43
Crimp/Weld/Bond 3
Other 127
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 October 12, 2018

www.medtronic.com/productperformance 626050