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          
% Survival 99.6 99.4 99.0 98.7 98.7          
#   4114 2550 1292 519 114          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5645
Cumulative Months of Follow-Up 133306
Number of Leads Active in Study 3969
Information 40

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 9
Failure to Capture 10
Failure to Sense 1
Impedance Out of Range 3
Insulation (not further defined) 2
Lead Dislodgement 12
Oversensing 1
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 85
Conductor Fracture 6
Extra Cardiac Stimulation 13
Failure to Capture 157
Failure to Sense 41
Impedance Out of Range 48
Insulation Breach 1
Lead Dislodgement 265
Oversensing 117
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants179371
Estimated Active USA Implants169280
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution384002
Information

USA Returned Product Analysis

Conductor Fracture 210
Insulation Breach 7
Crimp/Weld/Bond 0
Other 25
Information

WW Returned Product Analysis

Conductor Fracture 397
Insulation Breach 15
Crimp/Weld/Bond 0
Other 41
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 12, 2018

www.medtronic.com/productperformance 626050