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 8 yr    
% Survival 99.7 99.5 99.4 99.4 99.0 99.0 98.0 97.6    
#   1751 1473 1302 1095 912 730 517 127    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2190
Cumulative Months of Follow-Up 106688
Number of Leads Active in Study 820
Information 22

Qualifying Complications

Conductor Fracture 11
Failure to Capture 4
Failure to Sense 3
Impedance Out of Range 0
Lead Dislodgement 1
Oversensing 1
Other 2
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 39
Conductor Fracture 14
Extra Cardiac Stimulation 12
Failure to Capture 105
Failure to Sense 40
Impedance Out of Range 31
Lead Dislodgement 221
Oversensing 79
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants127955
Estimated Active USA Implants89023
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution256828
Information

USA Returned Product Analysis

Conductor Fracture 205
Insulation Breach 13
Crimp/Weld/Bond 0
Other 33
Information

WW Returned Product Analysis

Conductor Fracture 328
Insulation Breach 19
Crimp/Weld/Bond 0
Other 37
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 11, 2021

www.medtronic.com/productperformance 826050