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                
% Survival 98.5 96.5 93.4 91.0 88.2 84.4 81.5 79.3 78.6 77.2 71.5 69.0 66.6                
#   717 624 530 456 390 342 280 236 188 153 126 94 65                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 980
Cumulative Months of Follow-Up 55832
Number of Leads Active in Study 73
Information 129

Qualifying Complications

Conductor Fracture 73
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 48
Failure to Capture 32
Failure to Sense 19
Impedance Out of Range 19
Insulation Breach 5
Lead Dislodgement 22
Oversensing 35
Unspecified Clinical Failure 25
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants186160
Estimated Active USA Implants40652
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution233869
Information

USA Returned Product Analysis

Conductor Fracture 7983
Insulation Breach 37
Crimp/Weld/Bond 3
Other 104
Information

WW Returned Product Analysis

Conductor Fracture 9207
Insulation Breach 43
Crimp/Weld/Bond 3
Other 128
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 29, 2020

www.medtronic.com/productperformance 776050