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 90.2 89.2 86.2 85.9 82.6 80.5 79.9 76.8              
#   1161 978 853 702 584 477 395 325 271 215 180 137 88 52              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1340
Cumulative Months of Follow-Up 85454
Number of Leads Active in Study 110
Information 111

Qualifying Complications

Conductor Fracture 31
Failure to Capture 11
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 Implants4720
US Market Release1997-10-06
CE Approval Date
Estimated WW Distribution37255
Information

USA Returned Product Analysis

Conductor Fracture 88
Insulation Breach 32
Crimp/Weld/Bond 1
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 242
Insulation Breach 90
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 February 3, 2017

www.medtronic.com/productperformance 476050