6943 Sprint
Defibrillation
6943 Sprint
ALL
Information

Device Survival Probability


6943_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr                  
% Survival 98.6 97.7 96.6 95.6 93.5 91.8 90.5 89.5 86.6 85.6 82.3 81.4                  
#   1160 978 855 707 586 470 386 313 226 155 110 60                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1324
Cumulative Months of Follow-Up 80571
Number of Leads Active in Study 188
Information 98

Qualifying Complications

Conductor Fracture 27
Failure to Capture 8
Failure to Sense 7
Impedance Out of Range 8
Insulation (not further defined) 1
Lead Dislodgement 2
Oversensing 41
Other 1
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 Implants20609
Estimated Active USA Implants6081
US Market Release1997-10-06
CE Approval Date
Estimated WW Distribution31972
Information

USA Returned Product Analysis

Conductor Fracture 74
Insulation Breach 30
Crimp/Weld/Bond 1
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 218
Insulation Breach 86
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 January 31, 2014

www.medtronic.com/productperformance 301050