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

Device Survival Probability

4195_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr at 66.0 mo        
% Survival 99.3 98.7 98.5 98.3 97.5 97.5        
#   1178 904 633 354 168 88        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1458
Cumulative Months of Follow-Up 48282
Number of Leads Active in Study 753
Information 20

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 8
Failure to Capture 3
Impedance Out of Range 1
Insulation (not further defined) 2
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 29
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 Implants17080
Estimated Active USA Implants11779
US Market Release2008-08-15
CE Approval Date2005-05-13
Estimated WW Distribution42701
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 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
Hide this content

Data as of November 2, 2015

www.medtronic.com/productperformance 376051