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 at 90.0 mo    
% Survival 98.5 96.7 93.6 91.4 88.7 84.4 80.7 79.1    
#   699 604 504 410 326 216 97 58    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 879
Cumulative Months of Follow-Up 39661
Number of Leads Active in Study 282
Information 90

Qualifying Complications

Conductor Fracture 45
Failure to Capture 3
Failure to Sense 5
Impedance Out of Range 16
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 16
Other 2
Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 44
Failure to Capture 32
Failure to Sense 19
Impedance Out of Range 17
Insulation Breach 6
Lead Dislodgement 23
Oversensing 30
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186798
Estimated Active USA Implants72187
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution220885
Information

USA Returned Product Analysis

Conductor Fracture 6675
Insulation Breach 29
Crimp/Weld/Bond 3
Other 69
Information

WW Returned Product Analysis

Conductor Fracture 7790
Insulation Breach 34
Crimp/Weld/Bond 3
Other 103
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 January 31, 2014

www.medtronic.com/productperformance 301050