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 at 90.0 mo    
% Survival 99.6 99.5 99.2 98.9 98.3 97.7 97.5 97.5    
#   5469 4329 3405 2355 1337 609 178 59    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 7026
Cumulative Months of Follow-Up 248474
Number of Leads Active in Study 4033
Information 75

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 24
Extra Cardiac Stimulation 1
Failure to Capture 14
Failure to Sense 1
Impedance Out of Range 6
Insulation (not further defined) 3
Lead Dislodgement 16
Oversensing 5
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 139
Conductor Fracture 15
Extra Cardiac Stimulation 24
Failure to Capture 281
Failure to Sense 88
Impedance Out of Range 84
Insulation Breach 2
Lead Dislodgement 497
Oversensing 245
Information

Distribution Data

US Market Release2012-08-02
CE Approval Date2012-07-12
Registered USA Implants293139
Estimated Active USA Implants236822
US Market Release2012-08-02
CE Approval Date2012-07-12
Estimated WW Distribution651944
Information

USA Returned Product Analysis

Conductor Fracture 502
Insulation Breach 26
Crimp/Weld/Bond 1
Other 74
Information

WW Returned Product Analysis

Conductor Fracture 870
Insulation Breach 42
Crimp/Weld/Bond 1
Other 114
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 11, 2021

www.medtronic.com/productperformance 826050