4196 Attain Ability
Left-Heart Pacing
4196 Attain Ability
ALL
Information

Device Survival Probability

4196_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 98.0 97.2 96.5 95.9 95.5 94.7 94.2 94.2    
#   1861 1457 1132 861 648 460 240 59    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2268
Cumulative Months of Follow-Up 93832
Number of Leads Active in Study 519
Information 81

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 14
Failure to Capture 37
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 21
Other 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 2
Extra Cardiac Stimulation 92
Failure to Capture 60
Failure to Sense 1
Impedance Out of Range 9
Insulation Breach 1
Lead Dislodgement 205
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants68362
Estimated Active USA Implants47326
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution191280
Information

USA Returned Product Analysis

Conductor Fracture 22
Insulation Breach 2
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 32
Insulation Breach 3
Crimp/Weld/Bond 0
Other 16
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Double Curve
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Bipolar
More
Serial Number Prefix PVI
Lead Body Diameter 4.0 FR
Insulation Polyurethane (outer); SI-polyimide (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of October 12, 2018

www.medtronic.com/productperformance 626050