6949 Sprint Fidelis
Defibrillation
6949 Sprint Fidelis
ALL
Information

Device Survival Probability

6949_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr
% Survival 98.5 96.5 93.3 90.9 88.3 85.0 82.0 79.8 79.4 79.0
#   833 712 607 488 384 301 204 142 92 58

Product Surveillance Registry Results

Number of Leads Enrolled in Study 963
Cumulative Months of Follow-Up 51979
Number of Leads Active in Study 137
Information 109

Qualifying Complications

Conductor Fracture 61
Failure to Capture 4
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 15
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 17
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 Implants186702
Estimated Active USA Implants48609
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233863
Information

USA Returned Product Analysis

Conductor Fracture 7606
Insulation Breach 37
Crimp/Weld/Bond 3
Other 71
Information

WW Returned Product Analysis

Conductor Fracture 8788
Insulation Breach 42
Crimp/Weld/Bond 3
Other 102
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
Hide this content

Data as of July 31, 2017

www.medtronic.com/productperformance 501050