6943 Sprint
Defibrillation
6943 Sprint
ALL
Information

Device Survival Probability

6943_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 98.6 97.7 96.6 95.6 93.5 91.9 90.6 89.7 87.0 86.2 82.2 81.6 80.7                
#   1172 984 861 711 597 485 397 326 270 194 143 100 55                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1332
Cumulative Months of Follow-Up 83939
Number of Leads Active in Study 151
Information 103

Qualifying Complications

Conductor Fracture 29
Failure to Capture 9
Failure to Sense 7
Impedance Out of Range 8
Insulation (not further defined) 2
Lead Dislodgement 2
Oversensing 41
Other 2
Unspecified Clinical Failure 3
Information

US Acute Lead Observations

Cardiac Perforation 1
Failure to Capture 1
Failure to Sense 1
Impedance Out of Range 2
Insulation Breach 1
Oversensing 1
Information

Distribution Data

US Market Release1997-10-06
CE Approval Date
Registered USA Implants20610
Estimated Active USA Implants5793
US Market Release1997-10-06
CE Approval Date
Estimated WW Distribution32001
Information

USA Returned Product Analysis

Conductor Fracture 80
Insulation Breach 31
Crimp/Weld/Bond 1
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 229
Insulation Breach 87
Crimp/Weld/Bond 1
Other 23
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/One Coil
More
Serial Number Prefix TCE
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of February 9, 2015

www.medtronic.com/productperformance 351052