6945 Sprint
Defibrillation
6945 Sprint
ALL
Information

Device Survival Probability


6945_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 at 150 mo                
% Survival 99.4 98.7 98.1 97.5 96.6 95.7 95.1 93.9 92.6 92.0 90.6 89.8 89.8                
#   1003 820 656 525 406 308 273 230 184 149 120 84 66                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1176
Cumulative Months of Follow-Up 64536
Number of Leads Active in Study 122
Information 41

Qualifying Complications

Conductor Fracture 10
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 4
Impedance Out of Range 5
Oversensing 17
Other 1
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 2
Insulation Breach 2
Lead Dislodgement 4
Oversensing 7
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1997-09-26
CE Approval Date
Registered USA Implants42744
Estimated Active USA Implants12284
US Market Release1997-09-26
CE Approval Date
Estimated WW Distribution51237
Information

USA Returned Product Analysis

Conductor Fracture 134
Insulation Breach 41
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 163
Insulation Breach 49
Crimp/Weld/Bond 1
Other 14
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 Integrated Bipolar/Two Coils
More
Serial Number Prefix TDA
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