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 6 yr at 78.0 mo      
% Survival 99.2 98.6 98.4 98.2 97.7 97.2 97.2      
#   1242 1022 794 520 321 124 66      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1474
Cumulative Months of Follow-Up 57619
Number of Leads Active in Study 605
Information 24

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 4
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 4
Lead Dislodgement 30
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2008-08-15
CE Approval Date2005-05-13
Registered USA Implants17219
Estimated Active USA Implants11518
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution43380
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 2
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 10
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
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Data as of August 3, 2016

www.medtronic.com/productperformance 451050