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 91.0 88.2 84.4 81.5 79.3 78.6 77.2 73.1                    
#   849 729 621 525 431 336 220 156 98 66 55                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 978
Cumulative Months of Follow-Up 55317
Number of Leads Active in Study 84
Information 128

Qualifying Complications

Conductor Fracture 73
Failure to Capture 5
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 21
Other 1
Information

Customer Communications For This Model

Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 46
Failure to Capture 32
Failure to Sense 19
Impedance Out of Range 19
Insulation Breach 5
Lead Dislodgement 22
Oversensing 35
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants185957
Estimated Active USA Implants41559
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233869
Information

USA Returned Product Analysis

Conductor Fracture 7887
Insulation Breach 37
Crimp/Weld/Bond 3
Other 99
Information

WW Returned Product Analysis

Conductor Fracture 9115
Insulation Breach 43
Crimp/Weld/Bond 3
Other 123
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
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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 April 10, 2020

www.medtronic.com/productperformance 751050