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

Device Survival Probability

4195_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.3 98.7 98.6 98.6 98.1 98.1        
#   1136 825 527 279 89 55        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1441
Cumulative Months of Follow-Up 43390
Number of Leads Active in Study 827
Information 17

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 7
Failure to Capture 3
Impedance Out of Range 0
Insulation (not further defined) 1
Lead Dislodgement 4
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 28
Failure to Capture 19
Impedance Out of Range 3
Lead Dislodgement 29
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2008-08-15
CE Approval Date2005-05-13
Registered USA Implants16761
Estimated Active USA Implants12662
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution34389
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 1
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 8
Insulation Breach 3
Crimp/Weld/Bond 0
Other 12
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
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Data as of February 9, 2015

www.medtronic.com/productperformance 351052