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 at 114.0 mo
% Survival 98.5 96.5 93.3 90.9 88.3 84.9 81.9 79.6 79.2 78.6
#   825 701 590 466 380 296 200 137 79 61

Product Surveillance Registry Results

Number of Leads Enrolled in Study 954
Cumulative Months of Follow-Up 50198
Number of Leads Active in Study 167
Information 105

Qualifying Complications

Conductor Fracture 58
Failure to Capture 4
Failure to Sense 6
Impedance Out of Range 18
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 5
Lead Dislodgement 22
Oversensing 31
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186704
Estimated Active USA Implants50440
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233863
Information

USA Returned Product Analysis

Conductor Fracture 7509
Insulation Breach 36
Crimp/Weld/Bond 3
Other 70
Information

WW Returned Product Analysis

Conductor Fracture 8681
Insulation Breach 41
Crimp/Weld/Bond 3
Other 101
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 3, 2017

www.medtronic.com/productperformance 476050