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 15 yr            
% Survival 98.6 96.5 93.4 91.0 88.2 84.5 81.6 79.0 78.0 76.6 70.9 68.5 66.2 63.5 63.5            
#   719 626 532 458 392 343 281 236 187 152 125 96 79 65 54            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 986
Cumulative Months of Follow-Up 57726
Number of Leads Active in Study 35
Information 135

Qualifying Complications

Conductor Fracture 77
Failure to Capture 5
Failure to Sense 6
Impedance Out of Range 19
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 21
Other 3
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

Information

US Acute Lead Observations

Cardiac Perforation 10
Conductor Fracture 51
Failure to Capture 31
Failure to Sense 19
Impedance Out of Range 20
Insulation Breach 5
Lead Dislodgement 22
Oversensing 37
Unspecified Clinical Failure 24
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186212
Estimated Active USA Implants24351
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution236468
Information

USA Returned Product Analysis

Conductor Fracture 8157
Insulation Breach 37
Crimp/Weld/Bond 3
Other 119
Information

WW Returned Product Analysis

Conductor Fracture 9388
Insulation Breach 43
Crimp/Weld/Bond 3
Other 140
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 1, 2023

www.medtronic.com/productperformance 951051