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 10 yr at 126.0 mo                    
% Survival 99.2 98.6 98.2 97.7 97.3 96.9 96.4 95.6 95.2 95.2 93.9                    
#   1244 1073 924 743 613 494 373 254 161 82 57                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1486
Cumulative Months of Follow-Up 80502
Number of Leads Active in Study 278
Information 40

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 15
Failure to Capture 8
Impedance Out of Range 2
Insulation (not further defined) 5
Lead Dislodgement 5
Other 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 30
Failure to Capture 21
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 Implants17450
Estimated Active USA Implants6594
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution45750
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 7
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 October 11, 2021

www.medtronic.com/productperformance 826050