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 9 yr  
% Survival 100.0 99.8 99.2 97.3 95.0 92.1 91.5 90.8 90.8  
#   529 441 371 299 231 177 134 91 65  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 618
Cumulative Months of Follow-Up 33100
Number of Leads Active in Study 131
Information 28

Qualifying Complications

Conductor Fracture 15
Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 4
Oversensing 3
Other 0
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 17
Failure to Sense 3
Impedance Out of Range 10
Lead Dislodgement 24
Oversensing 18
Unspecified Clinical Failure 6
Information

Distribution Data

US Market Release2000-12-13
CE Approval Date1999-11-05
Registered USA Implants44719
Estimated Active USA Implants18781
US Market Release2000-12-13
CE Approval Date1999-11-05
Estimated WW Distribution117671
Information

USA Returned Product Analysis

Conductor Fracture 203
Insulation Breach 4
Crimp/Weld/Bond 1
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 391
Insulation Breach 14
Crimp/Weld/Bond 2
Other 8
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 November 8, 2019

www.medtronic.com/productperformance 726050