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 at 54.0 mo          
% Survival 98.0 97.3 96.9 96.5 95.9          
#   1603 1184 783 244 89          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2086
Cumulative Months of Follow-Up 58184
Number of Leads Active in Study 939
Information 54

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 12
Failure to Capture 18
Impedance Out of Range 1
Lead Dislodgement 20
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 78
Failure to Capture 50
Failure to Sense 1
Impedance Out of Range 7
Insulation Breach 1
Lead Dislodgement 168
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants61607
Estimated Active USA Implants49366
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution126422
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 0
Crimp/Weld/Bond 0
Other 10
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 1
Crimp/Weld/Bond 0
Other 14
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 February 9, 2015

www.medtronic.com/productperformance 351052