4195 Attain StarFix
Left-Heart Pacing
4195 Attain StarFix
ALL
Information

Device Survival Probability

4195_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr        
% Survival 99.2 98.6 98.4 98.2 97.6 97.6        
#   1225 976 718 441 252 76        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1468
Cumulative Months of Follow-Up 53432
Number of Leads Active in Study 681
Information 22

Qualifying Complications

Extra Cardiac Stimulation 9
Failure to Capture 3
Impedance Out of Range 1
Insulation (not further defined) 3
Lead Dislodgement 5
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 29
Failure to Capture 19
Impedance Out of Range 3
Lead Dislodgement 30
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2008-08-15
CE Approval Date2005-05-13
Registered USA Implants17198
Estimated Active USA Implants11604
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution43132
Information

USA Returned Product Analysis

Conductor Fracture 6
Insulation Breach 2
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 9
Insulation Breach 5
Crimp/Weld/Bond 0
Other 11
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Deployable Lobe Fixation
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Unipolar
More
Serial Number Prefix AAD
Lead Body Diameter 5.0 FR
Insulation Polyurethane
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid Yes
Hide this content

Data as of April 14, 2016

www.medtronic.com/productperformance 426050