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

Device Survival Probability

6935_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 11 yr                    
% Survival 99.5 99.2 98.9 98.6 98.4 97.9 97.3 96.4 95.4 94.6 94.6                    
#   2314 1908 1566 1259 1060 912 751 549 321 191 77                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2817
Cumulative Months of Follow-Up 145962
Number of Leads Active in Study 810
Information 58

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 21
Extra Cardiac Stimulation 1
Failure to Capture 7
Failure to Sense 1
Impedance Out of Range 7
Lead Dislodgement 7
Oversensing 8
Other 4
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 26
Conductor Fracture 4
Extra Cardiac Stimulation 1
Failure to Capture 28
Failure to Sense 14
Impedance Out of Range 26
Insulation Breach 1
Lead Dislodgement 65
Oversensing 63
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants64170
Estimated Active USA Implants37391
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution191217
Information

USA Returned Product Analysis

Conductor Fracture 414
Insulation Breach 12
Crimp/Weld/Bond 0
Other 42
Information

WW Returned Product Analysis

Conductor Fracture 796
Insulation Breach 31
Crimp/Weld/Bond 0
Other 77
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 TAU
Lead Body Diameter 8,2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of December 16, 2021

www.medtronic.com/productperformance 851050