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 14 yr              
% Survival 98.5 97.7 96.5 95.4 93.3 91.4 90.1 89.2 86.2 85.9 82.5 80.5 79.9 77.1              
#   1161 981 855 702 584 477 394 324 270 214 182 143 95 57              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1339
Cumulative Months of Follow-Up 85794
Number of Leads Active in Study 70
Information 113

Qualifying Complications

Conductor Fracture 32
Failure to Capture 12
Failure to Sense 7
Impedance Out of Range 9
Insulation (not further defined) 2
Lead Dislodgement 2
Oversensing 44
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 Implants20581
Estimated Active USA Implants4633
US Market Release1997-10-06
CE Approval Date
Estimated WW Distribution37257
Information

USA Returned Product Analysis

Conductor Fracture 89
Insulation Breach 33
Crimp/Weld/Bond 1
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 246
Insulation Breach 91
Crimp/Weld/Bond 1
Other 22
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 July 31, 2017

www.medtronic.com/productperformance 501050