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 14 yr              
% Survival 98.6 96.5 93.4 91.0 88.2 84.5 81.6 79.1 78.3 77.0 71.3 68.8 66.6 63.7              
#   719 626 532 458 392 344 282 236 188 153 126 97 79 51              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 982
Cumulative Months of Follow-Up 56762
Number of Leads Active in Study 58
Information 132

Qualifying Complications

Conductor Fracture 76
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 Implants186295
Estimated Active USA Implants25513
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution236463
Information

USA Returned Product Analysis

Conductor Fracture 8083
Insulation Breach 37
Crimp/Weld/Bond 3
Other 107
Information

WW Returned Product Analysis

Conductor Fracture 9323
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 December 16, 2021

www.medtronic.com/productperformance 851050