6948 Sprint Fidelis
Defibrillation
6948 Sprint Fidelis
ALL
Information

Device Survival Probability

6948_SURV
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    at 0.0 mo                  
% Survival 100.0                  
#   0                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 39
Cumulative Months of Follow-Up 2298
Number of Leads Active in Study 4
Information 4

Qualifying Complications

Conductor Fracture 3
Failure to Capture 0
Impedance Out of Range 1
Other 0
Information

Customer Communications For This Model

Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 7
Lead Dislodgement 7
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants10343
Estimated Active USA Implants2699
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution28026
Information

USA Returned Product Analysis

Conductor Fracture 210
Insulation Breach 3
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 548
Insulation Breach 4
Crimp/Weld/Bond 0
Other 9
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
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 LFH
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