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                
% Survival 99.4 98.7 98.1 97.5 96.6 95.8 95.1 93.9 92.6 92.1 90.7 89.9 89.9                
#   1006 821 657 525 406 311 274 230 185 153 123 102 64                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1180
Cumulative Months of Follow-Up 65395
Number of Leads Active in Study 116
Information 42

Qualifying Complications

Conductor Fracture 10
Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 4
Impedance Out of Range 5
Oversensing 18
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
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 Implants42743
Estimated Active USA Implants12115
US Market Release1997-09-26
CE Approval Date
Estimated WW Distribution51243
Information

USA Returned Product Analysis

Conductor Fracture 139
Insulation Breach 41
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 168
Insulation Breach 50
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 August 3, 2014

www.medtronic.com/productperformance 326050