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

Device Survival Probability


4195_SURV
    1 yr 2 yr 3 yr 4 yr at 54 mo          
% Survival 99.1 98.5 98.1 98.1 98.1          
#   981 628 349 106 58          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1375
Cumulative Months of Follow-Up 33402
Number of Leads Active in Study 918
Information 17

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 8
Failure to Capture 4
Insulation (not further defined) 1
Lead Dislodgement 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 23
Failure to Capture 15
Impedance Out of Range 3
Lead Dislodgement 25
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2008-08-15
CE Approval Date2005-05-13
Registered USA Implants15718
Estimated Active USA Implants12235
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution32506
Information

USA Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 4
Insulation Breach 2
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 January 31, 2014

www.medtronic.com/productperformance 301050