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 11 yr 12 yr 13 yr at 162.0 mo              
% Survival 98.5 96.5 93.4 91.0 88.2 84.4 81.5 79.0 78.2 76.9 71.2 68.7 66.4 65.4              
#   717 624 530 456 390 342 281 235 187 152 125 96 74 56              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 981
Cumulative Months of Follow-Up 56096
Number of Leads Active in Study 68
Information 130

Qualifying Complications

Conductor Fracture 74
Failure to Capture 5
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 21
Other 2
Information

Customer Communications For This Model

Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 51
Failure to Capture 32
Failure to Sense 19
Impedance Out of Range 19
Insulation Breach 5
Lead Dislodgement 22
Oversensing 36
Unspecified Clinical Failure 24
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186231
Estimated Active USA Implants25641
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution236463
Information

USA Returned Product Analysis

Conductor Fracture 8073
Insulation Breach 37
Crimp/Weld/Bond 3
Other 107
Information

WW Returned Product Analysis

Conductor Fracture 9316
Insulation Breach 43
Crimp/Weld/Bond 3
Other 132
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 October 11, 2021

www.medtronic.com/productperformance 826050