6945 Sprint
Defibrillation
6945 Sprint
ALL
Information

Device Survival Probability

6945_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 at 162.0 mo              
% Survival 99.4 98.7 98.1 97.5 96.6 95.8 95.1 93.9 92.6 91.6 90.3 89.6 89.6 89.6              
#   1017 824 660 528 407 311 274 230 186 155 129 106 73 51              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1186
Cumulative Months of Follow-Up 65992
Number of Leads Active in Study 94
Information 43

Qualifying Complications

Conductor Fracture 10
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 4
Impedance Out of Range 7
Oversensing 18
Other 0
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
Impedance Out of Range 1
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 Implants42741
Estimated Active USA Implants11761
US Market Release1997-09-26
CE Approval Date
Estimated WW Distribution51246
Information

USA Returned Product Analysis

Conductor Fracture 140
Insulation Breach 43
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 169
Insulation Breach 52
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
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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 February 9, 2015

www.medtronic.com/productperformance 351052