6944 Sprint Quattro
Defibrillation
6944 Sprint Quattro
ALL
Information

Device Survival Probability

6944_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr at 102.0 mo  
% Survival 100.0 99.8 99.2 97.2 94.9 92.3 91.5 90.5 90.5  
#   524 439 364 290 215 158 107 71 55  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 611
Cumulative Months of Follow-Up 31386
Number of Leads Active in Study 147
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 Implants44848
Estimated Active USA Implants19575
US Market Release2000-12-13
CE Approval Date1999-11-05
Estimated WW Distribution117397
Information

USA Returned Product Analysis

Conductor Fracture 194
Insulation Breach 4
Crimp/Weld/Bond 1
Other 6
Information

WW Returned Product Analysis

Conductor Fracture 379
Insulation Breach 13
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
Hide this content

Data as of October 12, 2018

www.medtronic.com/productperformance 626050