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 7 yr 8 yr 9 yr at 114.0 mo
% Survival 99.2 98.6 98.3 97.8 97.3 97.0 96.5 95.8 95.3 95.3
#   1270 1089 927 736 593 444 307 184 97 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1486
Cumulative Months of Follow-Up 76937
Number of Leads Active in Study 334
Information 36

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 13
Failure to Capture 7
Impedance Out of Range 2
Insulation (not further defined) 5
Lead Dislodgement 5
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 29
Failure to Capture 21
Impedance Out of Range 4
Lead Dislodgement 29
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release2008-08-15
CE Approval Date2005-05-13
Registered USA Implants17413
Estimated Active USA Implants10236
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution44398
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 3
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 13
Insulation Breach 6
Crimp/Weld/Bond 0
Other 6
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
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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 April 10, 2020

www.medtronic.com/productperformance 751050