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 37
Cumulative Months of Follow-Up 1604
Number of Leads Active in Study 13
Information 4

Qualifying Complications

Conductor Fracture 3
Impedance Out of Range 1
Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 6
Lead Dislodgement 7
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2004-09-02
CE Approval Date
Registered USA Implants10378
Estimated Active USA Implants4399
US Market Release2004-09-02
CE Approval Date
Estimated WW Distribution22915
Information

USA Returned Product Analysis

Conductor Fracture 172
Insulation Breach 2
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 483
Insulation Breach 3
Crimp/Weld/Bond 0
Other 8
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 August 3, 2014

www.medtronic.com/productperformance 326050