6943 Sprint
Defibrillation
6943 Sprint
ALL
Information

Device Survival Probability

6943_SURV
Loading...











    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 98.5 97.7 96.5 95.4 93.3 91.6 90.3 89.6 86.6 86.2 83.1 81.3 80.6 79.6              
#   1155 969 846 700 581 475 393 323 269 213 165 120 77 55              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1336
Cumulative Months of Follow-Up 84137
Number of Leads Active in Study 118
Information 107

Qualifying Complications

Conductor Fracture 30
Failure to Capture 11
Failure to Sense 7
Impedance Out of Range 8
Insulation (not further defined) 2
Lead Dislodgement 2
Oversensing 42
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 Implants20591
Estimated Active USA Implants4857
US Market Release1997-10-06
CE Approval Date
Estimated WW Distribution37251
Information

USA Returned Product Analysis

Conductor Fracture 85
Insulation Breach 31
Crimp/Weld/Bond 1
Other 5
Information

WW Returned Product Analysis

Conductor Fracture 239
Insulation Breach 88
Crimp/Weld/Bond 1
Other 23
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
Hide this content

Data as of April 14, 2016

www.medtronic.com/productperformance 426050