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 at 126.0 mo                    
% Survival 99.5 99.2 98.9 98.6 98.4 98.0 97.4 96.8 95.4 95.4 95.4                    
#   2292 1886 1534 1230 1046 889 714 473 254 121 78                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2784
Cumulative Months of Follow-Up 140379
Number of Leads Active in Study 834
Information 53

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 20
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 7
Lead Dislodgement 7
Oversensing 7
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 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 Implants63868
Estimated Active USA Implants37216
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution189878
Information

USA Returned Product Analysis

Conductor Fracture 409
Insulation Breach 12
Crimp/Weld/Bond 0
Other 42
Information

WW Returned Product Analysis

Conductor Fracture 791
Insulation Breach 30
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 October 11, 2021

www.medtronic.com/productperformance 826050