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 at 42.0 mo            
% Survival 97.7 97.0 96.4 96.4            
#   1492 996 385 165            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1969
Cumulative Months of Follow-Up 46224
Number of Leads Active in Study 1061
Information 52

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 13
Failure to Capture 18
Impedance Out of Range 2
Lead Dislodgement 18
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 69
Failure to Capture 37
Failure to Sense 1
Impedance Out of Range 6
Insulation Breach 1
Lead Dislodgement 137
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants55658
Estimated Active USA Implants45724
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution112854
Information

USA Returned Product Analysis

Conductor Fracture 9
Insulation Breach 0
Crimp/Weld/Bond 0
Other 8
Information

WW Returned Product Analysis

Conductor Fracture 14
Insulation Breach 1
Crimp/Weld/Bond 0
Other 9
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 January 31, 2014

www.medtronic.com/productperformance 301050