6947M Sprint Quattro Secure
Defibrillation
6947M Sprint Quattro Secure
ALL
Information

Device Survival Probability

6947M_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo    
% Survival 99.7 99.5 99.3 99.3 99.0 99.0 98.5 98.5    
#   1730 1459 1288 1074 886 706 382 167    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2166
Cumulative Months of Follow-Up 102428
Number of Leads Active in Study 851
Information 17

Qualifying Complications

Conductor Fracture 9
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 0
Lead Dislodgement 1
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 33
Conductor Fracture 9
Extra Cardiac Stimulation 11
Failure to Capture 99
Failure to Sense 37
Impedance Out of Range 28
Lead Dislodgement 208
Oversensing 74
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants121904
Estimated Active USA Implants106264
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution240734
Information

USA Returned Product Analysis

Conductor Fracture 173
Insulation Breach 12
Crimp/Weld/Bond 0
Other 30
Information

WW Returned Product Analysis

Conductor Fracture 288
Insulation Breach 18
Crimp/Weld/Bond 0
Other 34
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/Two Coils
More
Serial Number Prefix TDK
Lead Body Diameter 8.6 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style DF4-LLHH
High Voltage Connector DF4-LLHH
Steroid Yes
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Data as of October 29, 2020

www.medtronic.com/productperformance 776050