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 at 78.0 mo      
% Survival 100.0 99.7 99.1 97.3 95.4 95.4 95.4      
#   494 391 274 175 85 59 55      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 589
Cumulative Months of Follow-Up 23792
Number of Leads Active in Study 219
Information 15

Qualifying Complications

Conductor Fracture 8
Failure to Capture 1
Failure to Sense 1
Impedance Out of Range 2
Oversensing 2
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Conductor Fracture 2
Failure to Capture 16
Failure to Sense 3
Impedance Out of Range 10
Lead Dislodgement 22
Oversensing 13
Unspecified Clinical Failure 6
Information

Distribution Data

US Market Release2000-12-13
CE Approval Date1999-11-05
Registered USA Implants44469
Estimated Active USA Implants20456
US Market Release2000-12-13
CE Approval Date1999-11-05
Estimated WW Distribution113262
Information

USA Returned Product Analysis

Conductor Fracture 154
Insulation Breach 4
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 319
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 April 14, 2016

www.medtronic.com/productperformance 426050