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 9 yr 10 yr at 126.0 mo                    
% Survival 99.7 99.5 99.4 99.4 99.0 98.9 98.1 97.8 97.3 97.1 97.1                    
#   1834 1547 1363 1157 1002 838 697 575 453 222 94                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2378
Cumulative Months of Follow-Up 128937
Number of Leads Active in Study 693
Information 28

Qualifying Complications

Conductor Fracture 15
Failure to Capture 4
Failure to Sense 4
Impedance Out of Range 1
Lead Dislodgement 1
Oversensing 2
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 40
Conductor Fracture 15
Extra Cardiac Stimulation 12
Failure to Capture 117
Failure to Sense 46
Impedance Out of Range 37
Insulation Breach 1
Lead Dislodgement 238
Oversensing 85
Information

Distribution Data

US Market Release2012-02-13
CE Approval Date2010-03-12
Registered USA Implants135943
Estimated Active USA Implants93778
US Market Release2012-02-13
CE Approval Date2010-03-12
Estimated WW Distribution280102
Information

USA Returned Product Analysis

Conductor Fracture 248
Insulation Breach 15
Crimp/Weld/Bond 1
Other 37
Information

WW Returned Product Analysis

Conductor Fracture 381
Insulation Breach 21
Crimp/Weld/Bond 1
Other 43
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
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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 December 1, 2023

www.medtronic.com/productperformance 951051