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                    
#   845 726 619 522 425 316 216 148 94 66 55                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 977
Cumulative Months of Follow-Up 54360
Number of Leads Active in Study 98
Information 125

Qualifying Complications

Conductor Fracture 71
Failure to Capture 5
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 20
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 46
Failure to Capture 31
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 Implants186697
Estimated Active USA Implants45538
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233866
Information

USA Returned Product Analysis

Conductor Fracture 7769
Insulation Breach 37
Crimp/Weld/Bond 3
Other 90
Information

WW Returned Product Analysis

Conductor Fracture 8963
Insulation Breach 43
Crimp/Weld/Bond 3
Other 114
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 April 11, 2019

www.medtronic.com/productperformance 651050