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 8 yr 9 yr at 114.0 mo
% Survival 99.6 99.5 99.2 98.9 98.6 98.2 97.7 97.4 97.0 97.0
#   6732 5312 4334 3508 2833 2131 1302 634 259 139

Product Surveillance Registry Results

Number of Leads Enrolled in Study 9312
Cumulative Months of Follow-Up 371545
Number of Leads Active in Study 4439
Information 102

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 43
Extra Cardiac Stimulation 1
Failure to Capture 15
Failure to Sense 1
Impedance Out of Range 9
Insulation (not further defined) 3
Lead Dislodgement 19
Oversensing 5
Other 3
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 183
Conductor Fracture 21
Extra Cardiac Stimulation 31
Failure to Capture 422
Failure to Sense 146
Impedance Out of Range 126
Insulation Breach 3
Lead Dislodgement 633
Oversensing 327
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants373555
Estimated Active USA Implants306381
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution857806
Information

USA Returned Product Analysis

Conductor Fracture 735
Insulation Breach 35
Crimp/Weld/Bond 1
Other 99
Information

WW Returned Product Analysis

Conductor Fracture 1231
Insulation Breach 52
Crimp/Weld/Bond 2
Other 154
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 December 1, 2023

www.medtronic.com/productperformance 951051