6935M Sprint Quattro Secure S
Defibrillation
6935M Sprint Quattro Secure S
ALL
Information

Device Survival Probability

6935M_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr      
% Survival 99.6 99.5 99.2 98.9 98.4 98.0 98.0      
#   5238 4125 3152 1952 1007 403 52      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 6768
Cumulative Months of Follow-Up 227023
Number of Leads Active in Study 4044
Information 62

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 19
Extra Cardiac Stimulation 1
Failure to Capture 13
Failure to Sense 1
Impedance Out of Range 5
Insulation (not further defined) 2
Lead Dislodgement 15
Oversensing 2
Other 2
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 123
Conductor Fracture 11
Extra Cardiac Stimulation 22
Failure to Capture 235
Failure to Sense 72
Impedance Out of Range 71
Insulation Breach 2
Lead Dislodgement 419
Oversensing 203
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants254918
Estimated Active USA Implants235866
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution547896
Information

USA Returned Product Analysis

Conductor Fracture 391
Insulation Breach 17
Crimp/Weld/Bond 0
Other 64
Information

WW Returned Product Analysis

Conductor Fracture 682
Insulation Breach 29
Crimp/Weld/Bond 0
Other 98
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 TDL
Lead Body Diameter 2.8 mm (8.4 Fr)
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style DF4-LLHO
High Voltage Connector DF4-LLHO
Steroid Yes
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Data as of October 29, 2020

www.medtronic.com/productperformance 776050