6944 Sprint Quattro
Defibrillation
6944 Sprint Quattro
ALL
Information

Device Survival Probability

6944_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 100.0 99.8 99.2 97.2 94.7 91.9 91.1 89.9    
#   523 434 355 283 197 140 90 58    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 610
Cumulative Months of Follow-Up 30266
Number of Leads Active in Study 160
Information 27

Qualifying Complications

Conductor Fracture 14
Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 4
Oversensing 3
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 17
Failure to Sense 3
Impedance Out of Range 11
Lead Dislodgement 24
Oversensing 13
Unspecified Clinical Failure 6
Information

Distribution Data

US Market Release2000-12-13
CE Approval Date1999-11-05
Registered USA Implants44835
Estimated Active USA Implants19780
US Market Release2000-12-13
CE Approval Date1999-11-05
Estimated WW Distribution117079
Information

USA Returned Product Analysis

Conductor Fracture 186
Insulation Breach 4
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 368
Insulation Breach 12
Crimp/Weld/Bond 2
Other 14
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/Two Coils
More
Serial Number Prefix TDC
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 January 31, 2018

www.medtronic.com/productperformance 601051